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Imagio® 9100

by Seno Medical Instruments, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00864802000459 UDI-DI Date7 Jul 2023ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Optoacoustic/ultrasound imaging system
Model / Ref / Catalog
9100, 9100-000-02
Primary DI / UDI-DI
00864802000459
PMA Number
FDA Product Code
QNK
GMDN Term
Optoacoustic/ultrasound imaging system
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Optoacoustic/ultrasound imaging system

Cleared under the same submission (P200003)

Similar devices

Also classified as Optoacoustic/ultrasound imaging system.

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