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Ultrasound System, ZS3 ZS3-SP

by Zonare Medical Systems, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00851315007211 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Ultrasound System, ZS3
Generic Name
General-purpose ultrasound imaging system
Model / Reference
ZS3-SP
Primary DI / UDI-DI
00851315007211
FDA Product Code
IYO, IYN
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation Number
892.1560, 892.1550
GUDID distribution status
Not in Commercial Distribution

Other devices from Zonare Medical Systems, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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