CR Reader

FDA UDI

Class II (US FDA UDI)

by Konica Minolta Medical Imaging U.s.a., Inc.

Identity

Trade Name: CR Reader FDA UDI
Generic Name: Digital imaging cassette/phosphor plate FDA UDI
Device Name: CR Reader-R FDA UDI
Model / Reference: CRII60 FDA UDI
Description: CR Reader-R FDA UDI

Identifiers

Primary DI / UDI-DI: 00817100020391 FDA UDI
510(k) Number: K133120 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

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

Category: Digital imaging cassette/phosphor plate

CR Reader by Konica Minolta Medical Imaging U.s.a., 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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DIRECTVIEW CR Cassette with PQ Screen — CARESTREAM HEALTH, INC. · Class II
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 Cassettes for Vita Systems — CARESTREAM HEALTH, INC. · Class II

Cleared under the same submission

K133120 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 Medical Imaging U.s.a., Inc.

Sources (1)

FDA UDI 32149235-c12e-4cd0-ab8e-f393ff7d7436 35 fields · synced May 31, 2026