Identity
- Trade Name
- CR Cassettes for Vita Systems FDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Device Name
- CARESTREAM CR Cassette 28x35 / 11x14 FDA UDI
- Model / Reference
- CR Cassettes for Vita Systems FDA UDI
- Description
- CARESTREAM CR Cassette 28x35 / 11x14 FDA UDI
Identifiers
- Catalog Number
- 8216368 FDA UDI
- Primary DI / UDI-DI
- 60889978216369 FDA UDI
- 510(k) Number
- K945039 FDA UDI
- FDA Product Code
- IXA FDA UDI
- GMDN Term
- Digital imaging cassette/phosphor plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1850 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
No
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
No
FDA UDI
Category: Digital imaging cassette/phosphor plate
CR Cassettes for Vita Systems by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Digital imaging cassette/phosphor plate.
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Cleared under the same submission
K945039 also covers:
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC.
- Point-of-Care CR Cassette with Screen Type A — CARESTREAM HEALTH, INC.
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
- Carestream Health, Inc.
Sources (1)
- FDA UDI 68b7d3f8-d10d-44c2-a3f3-a5b739a3abcc 36 fields · synced Jun 8, 2026