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

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 :

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 21501813884

Nama Dagang / Merek : FUJIFILM Digital Mammography System AMULET Innovality

Kelompok / Kelas Resiko : Elektromedik Radiasi / C

Kategori Produk : Peralatan Radiologi

Sub Kategori : Peralatan Radiologi Diagnostik

Jenis Produk : Mammographic x-ray system.

Tipe / Ukuran : FDR MS-3500

Kemasan
Nama Produsen / Pabrikan
Nama Pendaftar
Atas dasar lisensi dari
: Unit
: FUJIFILM TECHNO PRODUCTS CO., LTD., Japan
Untuk FUJIFILM CORPORATION, Japan
: PT. FUJIFILM INDONESIA, DKI Jakarta
: -

Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 06 Desember 2024.
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 dari Nomor Izin Edar Alat Kesehatan
KEMENKES RI AKL 21501813884 tanggal 7 Juni 2018. 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.

Jakarta, 09 April 2021

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 21501813884

No. Deskripsi Tipe / Kode

1 Face guard -
2 24×30 compression plate (High) -
3 X-ray power radiation cable -
4 Chest wall pad *1 -
5 *1 Replacement parts for a chest wall pad and axilla pads are -
optional
6 Axillary pad L -
7 Axillary pad R -
8 Fuse -
9 Operation desk -
10 Operation manual, supplied documentation -
11 CD-ROM (Reference Guide) -
12 Stand anchor -
13 24×30 compression plate (Low) -
14 24×30 compression plate (Shift) -
15 24×30 compression plate (Shift Small) -
16 24×30H compression plate (Flex) -
17 24×30H compression plate (FS) -
18 18×24 compression plate (Low) -
19 18×24 compression plate (High) -
20 18×24 compression plate (Small) -
21 18×24L compression plate (Flex) -
22 18×24L compression plate (FS) -
23 18×24 compression plate (FS Small) -
24 18×24 compression plate (Shift P) -
25 18×24 compression plate (Shift P Small) -
26 18×24 compression plate (FS Shift P) -
27 Rectangle spot compression plate -
28 Compression plate for axilla radiography -
29 Compression plate for magnifications -
30 Rectangle spot magnification compression plate -
31 Round spot compression plate -
32 Round spot magnification compression plate -
33 2D biopsy compression plate -
34 Magnification table -
35 Remote exposure hand switch -
36 Remote exposure foot switch -
37 Protective shield -
38 Protective shield cover -

Lampiran 1 dari 2 Halaman

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

No. Deskripsi Tipe / Kode

39 Monitor arm -
40 Chest wall pad *2 -
41 Axillary pad L *2 -
42 Axillary pad R *2 -
43 Biopsy positioner (FDR-2000BPY) -
44 Lateral approach kit -
45 Stereo up-grade kit -
46 Tomosynthesis exposure software -
47 Tomosynthesis exposure software Excellent -
48 Tomosynthesis biopsysoftware -
49 Shielding Plate -
50 Under armlest -
51 Face guard T -
52 Foot switch array modification kit Frip Type -
53 Foot switch array modification kit Cross Type -
54 Compression plate storage holder -
55 1 Shot Phantom M Plus 24x30 -
56 CEDM Software -

Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang
tercantum dalam lampiran ini

Jakarta, 09 April 2021

Lampiran 2 dari 2 Halaman

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.
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Minimum necessary interval between successive exposures

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Do not make exposures more than 60 times in an hour. Otherwise, X-ray exposure may be
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 Mammography Solution
AMULET Innovality

The new leader in the AMULET series. Tomosynthesis, 3D mammography and biopsy are all available.

FUJIFILM supports the Pink Ribbon Campaign for early detection of breast cancer
Lasting smiles for women worldwide
Innovation and quality in mammography
Unique new detector for fast, low dose exa

AMULET Innovality employs a direct-co

Amorphous Selenium (a-Se) which exhib
the mammographic X-ray spectrum. The
detector efficiently collects electrical sig

AMULET Innovality- the result of Fujifilm’s ongoing “innovation” and commitment both high resolution and low noise. Thi
realize a higher DQE (Detective Quant
to providing top “quality” mammography services. The Innovality utilises Fujifilm’s
pixel array of conventional TFT panels.
unique a-Se direct conversion flat panel detector (FPD)* to produce clear images HCP detector, AMULET Innovality create

with a low X-ray dose. This system makes use of intelligent AEC (i-AEC) combined size of 50 μm; the finest available with a

with a new image analysis technology to automatically optimize the X-ray dosage
 High quality images for easier diagnosis

Tomosynthesis: making it possible to observe the internal structure of the breast

Image Processing Pattern 1

Enhances spicula and calcifications while keeping maximum contrast
for the viewing of masses within the glandular tissue.

Two modes suitable for a range of clinical purposes

2D mammography image
U Acquisition angle: ±7.5°
ST (Standard) mode U Pixel size: 150/100 μm
HR (High Resolution

The smaller angular range and fast image acquisition allow With a larger acquisition a
Tomosynthesis scans to be quickly performed with a relatively This allows the region of i
low x-ray dose. brought into clearer focus

Depth
Depth
resolution
resolution
Image Processing Pattern 2
Maximizes the visualization of fine spiculations and calcification.

S-View ‒ synthesized 2D image – function is available

Tomosynthe
produces n
*Two types of image processing can be selected on AWS.
intervals bu
combining
With the S-
In breast tomosynthesis, the X-ray tube moves through an arc while added to t
Easy operation and patient comfort — features of the AMULET series Attune to every p

U˜Ìiˆ}i˜ÌÊ

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˜Ìiˆ}i˜ÌÊ

Ê …>ÃÊ >`Û>˜Ì>}iÃÊ ˆ˜Ê `ivˆ˜ˆ˜}Ê Ì…iÊ œ«Ìˆ“>Ê
AMULET Harmony incorporates a range of
`œÃiÊ vœÀÊ >˜Ê iÝ>“ˆ˜>̈œ˜Ê Vœ“«>Ài`Ê ÌœÊ Vœ˜Ûi˜Ìˆœ˜>Ê

Ê Pre-exposure
designed to maintain a harmonious exa
systems where the sensor position is fixed.
atmosphere of trust between mammograp
Through the analysis of information obtained from œÜ‡Ê
`œÃiÊ«ÀiŜÌʈ“>}iÃ]ʘÌiˆ}i˜ÌÊ

ʓ>ŽiÃʈÌÊ«œÃÈLiÊ̜Ê
consider the mammary gland density (breast type) when ◆ Fit Sweet Paddle
`ivˆ˜ˆ˜}Ê̅iÊ݇À>ÞÊi˜iÀ}ÞÊ>˜`ʏiÛiÊœvÊ`œÃiÊÀiµÕˆÀi`° intelligent AEC
B This compression paddle fits to the shape
Able to be used even in the presence of implants; be evenly applied while holding the brea
ˆ˜Ìiˆ}i˜ÌÊ

Ê i˜>LiÃÊ “œÀiÊ >VVÕÀ>ÌiÊ V>VՏ>̈œ˜Ê œvÊ tissue is adequately separated.
exposure parameters than is possible with conventional
˜>ÞâiÃʓ>““>ÀÞÊ}>˜`ÊÃÌÀÕVÌÕÀiÃ]Êv>ÌÊ`i˜ÃˆÌÞÊ>˜`Êi݈ÃÌi˜Viʜvʈ“«>˜Ì

Ê ÃÞÃÌi“Ã°Ê ÞÊ >œÜˆ˜}Ê Ì…iÊ ÕÃiÊ œvÊ >Õ̜“>̈VÊ iÝ«œÃÕÀiÊ
vœÀÊ Ì…iÊ ˆ“«>˜Ìi`Ê LÀi>ÃÌ]Ê ˜Ìiˆ}i˜ÌÊ

Ê V>˜Ê vÕÀ̅iÀÊ Exposure
enhance examination workflow. ­iÌiÀ“ˆ˜iÃÊ̅iʜ«Ìˆ“>ÊÌÞ«iʜvÊ8‡À>ÞÊ>˜`ʏiÛiÊœvÊ
dosage for the breast type)

U Patient information display

The information shown on the display A at the A B ◆ Mood lighting to ease patie
base of the exposure unit can be switched between
Warm indirect lighting is used to illuminate
patient information (ID, name, date of birth, etc.)
to relax and allowing examinations to be p
and positioning information (angle of swivel arm,
compression force and breast thickness).
Positioning information can also be confirmed on
◆ Decorative labels provide and a
the display B on the compression arm.
Five different stand labels are available t
can choose a stand appearance that best
U Automatic positioning of radiation field thus relieving patient stress and anxiety.

The radiation field automatically shifts to the ideal place for patient positioning depending on
the compression paddle used. For example, with the 18 ✕ 30 cm compression plate using an
18 ✕ Ó{ÊV“ÊÀ>`ˆ>̈œ˜Êvˆi`]Ê̅iÊÀ>`ˆ>̈œ˜Êvˆi`ÊÀi“>ˆ˜Ãʈ˜Ê̅iÊVi˜ÌiÀÊvœÀÊ̅iÊ

Ê«œÃˆÌˆœ˜]Êňv̈˜}Ê
to the upper portion of the detector when the gantry is rotated to a MLO or ML position.
ÌʈÃÊ«œÃÈLiÊ̜ÊV…>˜}iÊ̅iÊÀ>`ˆ>̈œ˜Êvˆi`ÊÈâiÊ>vÌiÀÊ«œÃˆÌˆœ˜ˆ˜}Ê̅iÊ«>̈i˜Ì°

A
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ht tp://www.fujifilm.com/product s/medical/index.html

The new leader in the AMULET series. Tomosynthesis, 3D mammography and