Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
persetujuan untuk diedarkan dengan :
ALAT KESEHATAN
Kemasan : Unit
Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 15 November 2026.
2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat
penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
3. Izin edar ini merupakan persetujuan perpanjangan dengan perubahan alamat distributor dan
aksesori dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 21501213717 tanggal 09
Oktober 2017. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.
4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
tersebut, pendaftar bersedia mengembalikan izin edar.
5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
persetujuan izin edar ini.
6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
kembali.
Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203
LAMPIRAN
NOMOR IZIN EDAR
ALAT KESEHATAN
KEMENKES RI AKL 21501213717
Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203
Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran ini
Catatan:
- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1
Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah.
- Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
PHILIPS CX50 Diagnostic Ultrasound System
Diproduksi oleh:
Philips Ultrasound, Inc.
22100 Bothell Everett Highway
Bothell, WA 98021-8431 USA
KEMENKES RI AKL
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A new class of
compact ultrasound
Philips CX50 CompactXtreme ultrasound
system specifications
This printed copy is not an official Philips hard copy, use for reference only
This
2 printed copy is not an official Philips hard copy, use for reference only
Optional portability
• Specially designed cart
• Wheeled travel case
Ethernet port • Additional AC adapter
39.10 cm (15 in)
high-resolution Video out
monitor
Two USB ports
Key advantages
• Premium performance anywhere
you need it
• Exceptional results on technically
Foot rest difficult patients
• Support for cardiology, general imaging,
vascular, pediatrics, intraoperative and
Twin wheel
Ob/Gyn exams
locking caster
This printed copy is not an official Philips hard copy, use for reference only
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The CX50 system combines premium imaging technologies and advanced optimization for exceptional image quality.
This
4 printed copy is not an official Philips hard copy, use for reference only
This printed copy is not an official Philips hard copy, use for reference only
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This
6 printed copy is not an official Philips hard copy, use for reference only
This printed copy is not an official Philips hard copy, use for reference only
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This
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The CX50 has sophisticated system controls to help you acquire the best
possible data on your patients, including many one-button optimization
controls that adjust thousands of system parameters.
This printed copy is not an official Philips hard copy, use for reference only
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This
10 printed copy is not an official Philips hard copy, use for reference only
This printed copy is not an official Philips hard copy, use for reference only
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This
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Linear array • 2D, steerable PW, CW, High PRF and color Doppler,
tissue Doppler, advanced XRES and multi-variate
L12-3 broadband linear array harmonic imaging
• 12 to 3 MHz extended operating frequency range • Adult cardiac, cephalic adult and TCD
• Fine pitch, high-resolution linear array, 160 elements • Supports biopsy guide capabilities
• 2D, steerable PW, high PRF and color Doppler, Color
Power Angio, SonoCT, advanced XRES and multivariate S5-1 sector array with PureWave technology
harmonic imaging • 5 to 1 MHz extended operating frequency range
• Vascular, small parts, musculoskeletal, regional anesthesia • Sector array, 80 elements
and acute care applications • 2D, steerable PW Doppler, CW Doppler, high PRF Doppler,
• Contrast application color Doppler, tissue Doppler, advanced XRES and multivariate
• Supports reusable, three-angle biopsy guide (14-23 gauge) harmonic imaging including contrast LVO
• Adult cardiac, general purpose abdominal, transcranial
Doppler (TCD), acute care and adult LVO applications
• Supports reusable three-angle, plastic biopsy guide
(14-23 gauge) and three-angle stainless steel biopsy guide
(14-23 gauge)
This
14 printed copy is not an official Philips hard copy, use for reference only
Tip
xMATRIX array
A B C Bending neck Gastroscope (shaft)
This printed copy is not an official Philips hard copy, use for reference only
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Renal O
Vascular O
Difficult O
Interventional
Cardiac Adult cardiac
Pediatric TEE
Congenital
Pediatric
Vascular Carotid O O O
Arterial O O O
Venous O O
Abdominal O
TCD
Intervention O
Vascular access O
Obstetrics Early OB O
General OB O O
Fetal echo O
Gynecology Pelvis O O
Fertility O O
Thyroid O O
Testicle O
Breast O O
Musculoskeletal Superficial O O O
Deep O
Acute FAST O
Lung O O
Vascular access O
Nerve Superficial O
Deep O O
Pediatric Head O
Abdomen O
Renal O
This
16 printed copy is not an official Philips hard copy, use for reference only
Renal O
Vascular O
Difficult
Interventional
Cardiac Adult cardiac O O
Pediatric TEE O
Congenital O
Pediatric O O O
Vascular Carotid
Arterial
Venous
Abdominal O
TCD O O
Intervention
Vascular access
Obstetrics Early OB
General OB
Fetal echo
Gynecology Pelvis
Fertility
Small parts Superficial
Thyroid
Testicle
Breast
Musculoskeletal Superficial
Deep
Acute FAST O
Lung
Vascular access
Nerve Superficial
Deep
Pediatric Head O
Abdomen O
Renal
This printed copy is not an official Philips hard copy, use for reference only
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This printed copy is not an official Philips hard copy, use for reference only
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This printed copy is not an official Philips hard copy, use for reference only
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System dimensions
Length 35.6 cm/14 in
Width 41.3 cm/16.25 in
Height 8.6 cm/3.4 in
Weight 7.3 kg/16.2 lb
Display 39.1 cm/15.4 in high-resolution display
with wide viewing angle
Physical features
• High-resolution display with wide viewing angle
• Laptop style alphanumeric QWERTY keyboard
• Ergonomic, integrated carrying handle
• USB footswitch
• Multiple transducer module option multiport adapter
connects up to three transducers
Mobility cart
• Weight: 47.4 kg/104.3 lb
• Width at base: 57.4 cm/22.6 in
• Depth including handle: 63.5 cm/25.0 in
• Height: adjustable from 90 cm/35.4 in to 108 cm/42.5 in
• Rear-mounted handle
• Casters: 5" casters provide total locking (directional and
rotational) engaged by the foot pedals
• Quick-release tray
– Simple latch system to secure CX50 system in place
– System’s integrated handle accessible from front
for secureׯmaneuverability
• Storage
– Two clear plastic storage trays 24 cm x 16 cm x 6 cm
with maximum weight of 2 kg
The CX50 is a laptop-sized ultrasound system you
– One USB peripheral tray 24 cm x 16 cm x 2.5 cm
can hand-carry or use on a specially designed cart.
with straps to secure devices less than 2 kg
– One handle-mounted clear plastic storage tray
– Transducer holders accommodate four transducers
– Multiple transducer, ECG and power cord cable hooks
conveniently positioned to facilitate cable management
– Rear-mounted USB and Ethernet port panel
– Optional multiport adapter allows simultaneous
connection up to three transducers
– Optional integrated B/W printer
– Input power to integrated B/W printer
• Input power to B/W printer and color printer
• USB hub with cables to:
– B/W printer
– Color printer
– CX50 USB
This
22 printed copy is not an official Philips hard copy, use for reference only
This printed copy is not an official Philips hard copy, use for reference only
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Services*
• Clinical applications support available
• On-cart transducer test provides confidence in your
transducer quality
• Philips Remote Services connectivity allows for many advanced
service features, including:
– Virtual on-site visits for both clinical and technical support,
providing fast resolution to issues and questions
– Remote clinical education
– Remote log file transfer decreases downtime by allowing
rapid diagnosis of problems by Call Center personnel
– Online Support Request
– Simplifies support engagement
– Provides fast response to clinical questions
and technical issues
– User can enter request directly on ultrasound system
– Proactive monitoring
New photo
– Helps prevent unscheduled downtime
needed
Maintenance – Monitors key system parameters
– Sends an alert to Philips Call Center so action can
• Easy customer access to air filter for cleaning be taken before system operation is affected
• System designed for easy replacement of key • Optional Utilization Report provides data to help manage
components by your facility’s biomedical engineers ultrasound assets
• Flexible RightFit service agreements to: – Track system and transducer usage
– Maximize uptime – Summarize data about exam types and duration
– Access Philips award-winning service organization – Provide data to help with credentialing and privileging
– Minimize risk – Identify referrals by exam type
This printed copy is not an official Philips hard copy, use for reference only