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Radlink Cassette CAS1417

by Radlink, Inc.

Radlink Cassette CAS1417 is a Class II device made by Radlink, Inc., cleared under FDA 510(k) K052938 on 17 Nov 2005 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00866389000198), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K052938

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00866389000198 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052938 Date17 Nov 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052938 decided 17 Nov 2005 Active
  • FDA GUDID UDI-DI 00866389000198 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052938
  2. Listed FDA GUDID 00866389000198

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Radlink Cassette
Generic name
Digital imaging cassette
Model / reference
CAS1417
Primary DI / UDI-DI
00866389000198
510(k) Number
FDA product code
MQB
GMDN term
Digital imaging cassette
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Digital imaging cassette

Cleared under the same submission (K052938)

Other devices from Radlink, Inc.

See all devices from Radlink, Inc. →

Properties

Other properties (15, all answered No)