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N/A KBM68303

by PENTAX of America, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333243150 UDI-DI Date12 Mar 2018ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Radiology information system
Model / Reference
KBM68303
Primary DI / UDI-DI
04961333243150
FDA Product Code
OUG
GMDN Term
Radiology information system
Device Class
Class I
Regulation Number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology information system

Other devices from PENTAX of America, Inc.

See all devices from PENTAX of America, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Serial Number

Other properties (10)

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