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DRX - Ascend System

by Carestream Health, Inc. 123 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 8 Jun 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 8 Jun 2026. What this means

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60889978604050 UDI-DI Date31 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Jun 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Stationary basic diagnostic x-ray system, analogue
Model / Ref / Catalog
DRX - Ascend System, 8604050
Primary DI / UDI-DI
60889978604050
510(k) Number
FDA Product Code
KPR
GMDN Term
Stationary basic diagnostic x-ray system, analogue
Device Class
Class II
Regulation Number
892.1680
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K011486)

Show all (12)

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No