Identity
- Trade Name
- CR HD5.0 GENERAL DETECTOR FDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Device Name
- CR HD5.0 GENERAL DETECTOR 15X30 FDA UDI
- Model / Reference
- CR HD5.0 GENERAL DETECTOR 15X30 FDA UDI
- Description
- CR HD5.0 GENERAL DETECTOR 15X30 FDA UDI
Identifiers
- Catalog Number
- ERMSG FDA UDI
- Primary DI / UDI-DI
- 05414904015612 FDA UDI
- 510(k) Number
- K141602 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Digital imaging cassette/phosphor plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 30 Centimeter FDA UDILength — 15 Centimeter FDA UDI
Category: Digital imaging cassette/phosphor plate
Cr Hd5.0 General Detector by Agfa Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digital imaging cassette/phosphor plate.
- DIRECTVIEW CR Cassette with HR Screen — CARESTREAM HEALTH, INC. · Class II
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC. · Class II
- REGIUS Cassette/Plate — Konica Minolta, Inc. · Class II
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC. · Class II
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC. · Class II
- REGIUS Cassette/Plate — Konica Minolta, Inc. · Class II
- DIRECTVIEW CR Gridded Cassette with PQ Screen — CARESTREAM HEALTH, INC. · Class I
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC. · Class II
Cleared under the same submission
K141602 also covers:
- CR HD5.0 AEC DETECTOR — Agfa Corp.
- CR HD5.0 AEC DETECTOR — Agfa Corp.
- CR HD5.0 AEC DETECTOR — Agfa Corp.
- CR HD5.0 FLFS CASSETTE — Agfa Corp.
- CR HD5.0 FLFS DETECTOR — Agfa Corp.
- CR HD5.0 GENERAL DETECTOR — Agfa Corp.
- CR HD5.0 GENERAL DETECTOR — Agfa Corp.
- CR HD5.0 GENERAL DETECTOR — Agfa Corp.
- CR HD5.0 GENERAL SR DETECTOR — Agfa Corp.
- CR MD4.0R FLFS CASSETTE — Agfa Corp.
- CR MD4.0R FLFS SET — Agfa Corp.
- CR MD4.0R GENERAL CASSETTE — Agfa Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Agfa Corp.
Sources (1)
- FDA UDI 52aaec73-237a-40b7-bb96-0801c239e75f 37 fields · synced May 29, 2026