Identity
- Trade Name
- 347Y100160 EUDAMEDSlide stopper V FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- Lateral Option EUDAMEDAdjust the depth that the needle is inserted. The slide stopper differs for each needle. Use a slide stopper that suits each type of needle being used. FDA UDI
- Model / Reference
- 04547410211351 EUDAMEDLATERAL NEEDLE STOPPER V E FDA UDI
- Description
- Adjust the depth that the needle is inserted. The slide stopper differs for each needle. Use a slide stopper that suits each type of needle being used. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410211351 EUDAMEDFDA UDI
- Basic UDI-DI
- 454741010100000000000913V EUDAMED
- 510(k) Number
- K133972 FDA UDI
- FDA Product Code
- MUE FDA UDI
- EMDN Code
- Z1103028099 MAMMOGRAPHY SYSTEMS - HARDWARE - OTHER EUDAMED
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1715 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary mammographic x-ray system, digital
Slide stopper V by FUJIFILM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stationary mammographic x-ray system, digital.
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia® Dimensions® — Hologic, Inc. · Class II
- Senographe Pristina — GE MEDICAL SYSTEMS, INC. · Class II
- 3Dimensions — Hologic, Inc. · Class III
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia® Dimensions® — Hologic, Inc. · Class II
- GIOTTO IMAGE — IMS GIOTTO SPA · Class II
Cleared under the same submission
K133972 also covers:
- 18x24 Compression plate (High) — FUJIFILM Corporation
- 18x24 Compression plate (Low) — FUJIFILM Corporation
- 18x24 Spot compression plate — FUJIFILM Corporation
- 18x24 comfort paddle (FS Small) — FUJIFILM Corporation
- 18x24 compression plate (Small) — FUJIFILM Corporation
- 18x24L comfort paddle (FS) — FUJIFILM Corporation
- 18x24L compression plate (Flex) — FUJIFILM Corporation
- 1Shot Phantom M Plus 24x30 — FUJIFILM Corporation
- 24x30 Compression plate (High) — FUJIFILM Corporation
- 24x30 Compression plate (Low) — FUJIFILM Corporation
- 24x30 compression plate (Shift Small) — FUJIFILM Corporation
- 24x30 compression plate (Shift) — FUJIFILM Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (2)
- FDA UDI 0a67cd6e-07e7-48be-bf7a-17d0239cd33d 35 fields · synced Jun 14, 2026
- EUDAMED 4080d5ee-806b-4f7a-aafd-f73fe11ac651 61 fields · synced Jun 14, 2026