REGIUS Cassette

FDA UDI

Class II (US FDA UDI)

by Konica Minolta, Inc.

Identity

Trade Name: REGIUS Cassette FDA UDI
Generic Name: Digital imaging cassette FDA UDI
Model / Reference: A3P5 FDA UDI

Identifiers

Primary DI / UDI-DI: 04560141933231 FDA UDI
510(k) Number: K103703 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Digital imaging cassette 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Digital imaging cassette

REGIUS Cassette by Konica Minolta, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K103703 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: Konica Minolta, Inc.

Sources (1)

FDA UDI a366083d-a4f5-4ca0-a186-466376e33132 34 fields · synced May 31, 2026