Identity
- Trade Name
- Magazine S FDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- Small magazine : 10”x12”, 26x36cm, 8”x10” film size FDA UDI
- Model / Reference
- DPX LITE MAGAZINE S : E FDA UDI
- Description
- Small magazine : 10”x12”, 26x36cm, 8”x10” film size FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410207743 FDA UDI
- 510(k) Number
- K962967 FDA UDI
- FDA Product Code
- LMC FDA UDI
- GMDN Term
- Diagnostic-imaging multiformat camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2040 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic-imaging multiformat camera
Magazine S by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K962967 also covers:
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
- FUJIFILM Corporation
Sources (1)
- FDA UDI d68afa9d-163a-464c-b4b3-00130c82911a 36 fields · synced Jun 1, 2026