Identity
- Trade Name
- CR MD4.0R GENERAL SET FDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Device Name
- CR MD4.0R GENERAL SET. 18CM X 24CM FDA UDI
- Model / Reference
- CR MD4.0R GENERAL SET 18X24 FDA UDI
- Description
- CR MD4.0R GENERAL SET. 18CM X 24CM FDA UDI
Identifiers
- Catalog Number
- E493N FDA UDI
- Primary DI / UDI-DI
- 05414904026793 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 18 Centimeter FDA UDIWidth — 24 Centimeter FDA UDI
Category: Digital imaging cassette/phosphor plate
Cr Md4.0r General Set 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 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.
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 f40c15ce-0b35-4ed7-9525-053796333e2e 37 fields · synced May 30, 2026