Cr Hd5.0 Aec Cassette

FDA UDI

Class II (US FDA UDI)

by Agfa Corp.

Identity

Trade Name: CR HD5.0 AEC CASSETTE FDA UDI
Generic Name: Digital imaging cassette FDA UDI
Device Name: CR HD5.0 AEC CASSETTE 35X43CM FDA UDI
Model / Reference: CR HD5.0 AEC CASSETTE 35X43 FDA UDI
Description: CR HD5.0 AEC CASSETTE 35X43CM FDA UDI

Identifiers

Catalog Number: 5PCQV FDA UDI
Primary DI / UDI-DI: 05414904044155 FDA UDI
510(k) Number: K111324 FDA UDI
FDA Product Code: MUE FDA UDI
GMDN Term: Digital imaging cassette FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1715 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 43 Centimeter FDA UDI
Length — 35 Centimeter FDA UDI

Category: Digital imaging cassette

Cr Hd5.0 Aec Cassette by Agfa Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K111324 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: Agfa Corp.

Sources (1)

FDA UDI 2ce919a3-e45a-49e5-bb30-7fca6c7a54af 37 fields · synced Jun 1, 2026