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Angiowave AngioWaveNet

by Angiowave Imaging, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00198715128956 UDI-DI Date9 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Angiowave
Generic Name
Fluoroscopic x-ray system operation software
Model / Reference
AngioWaveNet
Primary DI / UDI-DI
00198715128956
510(k) Number
FDA Product Code
QIH, OWB
GMDN Term
Fluoroscopic x-ray system operation software
Device Class
Class II
Regulation Number
892.2050, 892.1650
GUDID distribution status
In Commercial Distribution

Other devices from Angiowave Imaging, Inc.

  • AngioWaveNet

    Class II

Properties

  • Prescription Use
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No