Radlink Cassette

FDA UDI

Class II (US FDA UDI)

by Radlink, Inc.

Identity

Trade Name: Radlink Cassette FDA UDI
Generic Name: Digital imaging cassette FDA UDI
Device Name: The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation. This model is designed for 14"x17" plates. FDA UDI
Model / Reference: CAS1417 FDA UDI
Description: The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation. This model is designed for 14"x17" plates. FDA UDI

Identifiers

Primary DI / UDI-DI: 00866389000198 FDA UDI
510(k) Number: K052938 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Digital imaging cassette

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

Similar devices

Also classified as Digital imaging cassette.

CR HD5.0 AEC CASSETTE — Agfa Corp. · Class II
REGIUS Cassette — Konica Minolta, Inc. · Class II
CR HD5.0 FLFS CASSETTE — Agfa Corp. · Class II
CR MD4.0 GENERAL CASSETTE — Agfa Corp. · Class II
CR MD4.0T GENERAL CASSETTE — Agfa Corp. · Class II
CARESTREAM CR Cassette — CARESTREAM HEALTH, INC. · Class I
CR MD4.0T GENERAL CASSETTE — Agfa Corp. · Class II
CR HD5.0S GENERAL CASSETTE — Agfa Corp. · Class II

Cleared under the same submission

K052938 also covers:

Radlink CR Pro 2200 — RADLINK, INC.
Radlink Cassette — RADLINK, 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: Radlink, Inc.

Sources (1)

FDA UDI 2a26d11d-66b1-46e8-b109-40b19e5bbd67 34 fields · synced May 30, 2026