Identity
- Trade Name
- P-41 FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Model / Reference
- ACNN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560141947986 FDA UDI
- 510(k) Number
- K191645 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Indirect flat panel x-ray detector 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
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
MR Unsafe FDA UDI
Category: Indirect flat panel x-ray detector
P-41 by Konica Minolta, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indirect flat panel x-ray detector.
- DRX-Transportable System — CARESTREAM HEALTH, INC. · Class II
- DRX Plus 3543 Detector — CARESTREAM HEALTH, INC. · Class II
- DRX Plus 3543C Detector — CARESTREAM HEALTH, INC. · Class II
- LG — Lg Electronics · Class II
- DRX-1 Detector — CARESTREAM HEALTH, INC. · Class II
- PEDRA — Radisen Co., Ltd. · Class II
- DX-D 60G — Agfa Corp. · Class II
- ATAL 9 — PIXXGEN Corporation · Class II
Cleared under the same submission
K191645 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Konica Minolta, Inc.
Sources (1)
- FDA UDI 496f19f4-76b5-4719-a659-01bddafb10e8 34 fields · synced May 30, 2026