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Linear Mc 150

by Carestream Health, Inc. 4 variants

Linear Mc 150 (1058940) is a medical device (FDA Class II; FDA product code IZX, Collimator, manual, radiographic) made by Carestream Health, Inc., cleared under FDA 510(k) K810598 on 10 Apr 1981 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 60889971058942), active as of 8 Jun 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 8 Jun 2026

Documents

510(k) K810598

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60889971058942 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK810598 Date10 Apr 1981DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K810598 decided 10 Apr 1981 Active
  • FDA GUDID UDI-DI 60889971058942 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K810598
  2. Listed FDA GUDID 60889971058942

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Manual-aperture-control diagnostic x-ray system collimator, motorized
Model / Ref / Catalog
LINEAR MC 150, 1058940
Primary DI / UDI-DI
60889971058942
510(k) Number
FDA product code
IZX
GMDN term
Manual-aperture-control diagnostic x-ray system collimator, motorized
Device class
Class II
Regulation number
892.1610
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IZX (Collimator, manual, radiographic).

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

  • Serial number
Other properties (14, all answered No)