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Affiniti 50 Diagnostic Ultrasound System 989605410251

by Philips Ultrasound LLC

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838056244 UDI-DI Date31 Mar 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Affiniti 50 Diagnostic Ultrasound System
Generic Name
General-purpose ultrasound imaging system
Model / Reference
989605410251
Primary DI / UDI-DI
00884838056244
FDA Product Code
IYO, ITX, IYN
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation Number
892.1560, 892.1570, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose ultrasound imaging system

Other devices from Philips Ultrasound LLC

See all devices from Philips Ultrasound LLC →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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