18x24L compression plate (Flex)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 401Y100122 EUDAMED18x24L compression plate (Flex) FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- Compression plate EUDAMEDFDA UDI
- Model / Reference
- 04547410242133 EUDAMEDCOMP PLATE 18X24 FLEX HA E FDA UDI
- Description
- Compression plate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410242133 EUDAMEDFDA UDI
- Basic UDI-DI
- 454741010100000000000653U 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
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary mammographic x-ray system, digital
18x24L compression plate (Flex) by FUJIFILM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- 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
- 24x30H comfort paddle (FS) — 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 |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (2)
- FDA UDI f2031c9d-169a-4af0-9c58-e9eab4c2a511 36 fields · synced Jun 19, 2026
- EUDAMED b52e60f0-cc3f-4249-b14c-79dc440d3868 61 fields · synced Jun 19, 2026