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Novasight Hybrid Console NC201

by Conavi Medical 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 Number00628055603252 UDI-DI Date15 Sep 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  • Withdrawn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
Novasight Hybrid Console
Generic Name
Coronary optical coherence tomography system
Model / Reference
NC201
Primary DI / UDI-DI
00628055603252
510(k) Number
FDA Product Code
OBJ, NQQ, IYO
GMDN Term
Coronary optical coherence tomography system
Device Class
Class II
Regulation Number
870.1200, 892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252945)

Other devices from Conavi Medical Inc

See all devices from Conavi Medical 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