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5P1e Phased Array Transduder

by Carestream Health, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60889971750518 UDI-DIDate27 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 8 Jun 2026.

Specification

GUDID

Generic Name
General-purpose ultrasound imaging system
Model / Ref / Catalog
5P1e Phased Array Transduder, 1750512
Primary DI / UDI-DI
60889971750518
510(k) Number
FDA Product Code
ITX
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
Not in Commercial Distribution

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

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