Identity
- Trade Name
- REGIUS Cassette/Plate FDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Model / Reference
- KCKD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560141922730 FDA UDI
- 510(k) Number
- K092717 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
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: Digital imaging cassette/phosphor plate
REGIUS Cassette/Plate by Konica Minolta, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digital imaging cassette/phosphor plate.
- CR HD5.0 GENERAL DETECTOR — Agfa Corp. · Class II
- DIRECTVIEW CR Cassette with HR Screen — CARESTREAM HEALTH, INC. · Class II
- CR MD4.0R GENERAL SET — Agfa Corp. · Class II
- DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC. · Class II
- CR MD4.0R GENERAL SET — Agfa Corp. · Class II
- CR MD4.0T PLATE — Agfa Corp. · Class II
- CR Cassettes for Vita Systems — CARESTREAM HEALTH, INC. · Class II
- CR HD5.0 GENERAL DETECTOR — Agfa Corp. · Class II
Cleared under the same submission
K092717 also covers:
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette — Konica Minolta, Inc.
- REGIUS Cassette/Plate — Konica Minolta, Inc.
- REGIUS Cassette/Plate — Konica Minolta, Inc.
- REGIUS Cassette/Plate — Konica Minolta, Inc.
- REGIUS Cassette/Plate — Konica Minolta, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Konica Minolta, Inc.
Sources (1)
- FDA UDI 9bf6df90-53e3-4416-9c82-382db77d3c7d 34 fields · synced Jun 6, 2026