Identity
- Trade Name
- DIRECTVIEW CR Cassette with PQ Screen FDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Device Name
- 10SC 35X35CM DIRECTVIEW PQ SCR FDA UDI
- Model / Reference
- DIRECTVIEW CR Cassette with PQ Screen FDA UDI
- Description
- 10SC 35X35CM DIRECTVIEW PQ SCR FDA UDI
Identifiers
- Catalog Number
- 1933985 FDA UDI
- Primary DI / UDI-DI
- 60889971933980 FDA UDI
- 510(k) Number
- K040378 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Digital imaging cassette/phosphor plate
DIRECTVIEW CR Cassette with PQ Screen by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digital imaging cassette/phosphor plate.
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- CR MD4.0R GENERAL SET — Agfa Corp. · Class II
- REGIUS Cassette/Plate — Konica Minolta, Inc. · Class II
- CR MD4.0T PLATE — Agfa Corp. · Class II
- CR HD5.0 GENERAL DETECTOR — Agfa Corp. · Class II
- REGIUS Cassette/Plate — Konica Minolta, Inc. · Class II
- CR Reader — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
Cleared under the same submission
K040378 also covers:
- DIRECTVIEW CR Cassette with HR Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with HR Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC.
- DIRECTVIEW CR Cassette with PQ Screen — 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 f437a2b2-9d95-4e54-a064-17051d8b87cf 36 fields · synced Jun 8, 2026