Identity
- Trade Name
- FUJI IMAGING PLATE HR-BD EUDAMEDFUJI IMAGING PLATE FDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- FUJI IMAGING PLATE HR-BD EUDAMEDThe Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images. FDA UDI
- Model / Reference
- 04547410059434 EUDAMEDIP HR-BD 24X30CM 2 E FDA UDI
- Description
- The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images. FDA UDI
Identifiers
- Catalog Number
- 47410-05943 FDA UDI
- Primary DI / UDI-DI
- 04547410059434 EUDAMEDFDA UDI
- Basic UDI-DI
- 454741010100000000000163F EUDAMED
- 510(k) Number
- K862414 FDA UDI
- FDA Product Code
- EAM FDA UDI
- EMDN Code
- Z11060285 DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - CONSUMABLES EUDAMED
- GMDN Term
- Computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1960 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
No
Category: Computed radiography digital imaging scanner
Fuji Imaging Plate by FUJIFILM Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Computed radiography digital imaging scanner.
- CANON INC. — CANON INC. · Class II
- DX-M — Agfa Corp. · Class II
- Vita XE CR System — CARESTREAM HEALTH, INC. · Class II
- CANON INC. — CANON INC. · Class II
- Radlink CR Pro 2200 — RADLINK, INC. · Class II
- GMR40 Retrofit Kit — Neurologica Corporation · Class II
- CANON INC. — CANON INC. · Class II
- Vita Flex CR System — CARESTREAM HEALTH, INC. · Class II
Cleared under the same submission
K862414 also covers:
- 15X30 IP ADAPTER — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
- FUJI IMAGING PLATE — FUJIFILM Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (2)
- FDA UDI 08ca01d0-2e03-4b80-9dcf-b7d79154752e 37 fields · synced Jul 8, 2026
- EUDAMED 1b202aa2-2196-4537-85c1-b0b1c7d0904a 61 fields · synced Jul 8, 2026