Skip to content

Imagio® 8500

by Seno Medical Instruments, 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 Number00864802000466 UDI-DI Date7 Jul 2023ListedStatusListed 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  • Withdrawn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
Imagio®
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held
Model / Ref / Catalog
8500, 8500-185-00
Primary DI / UDI-DI
00864802000466
FDA Product Code
ITX, IYO, IYN
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held
Device Class
Class II
Regulation Number
892.1570, 892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Other devices from Seno Medical Instruments, 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