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NovaPACS 9.1.5

by Novarad Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 NumberB109NOVAPACS9150 UDI-DIDate17 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2956-2020 FDA Class II initiated 10 Sep 2019

    The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
NovaPACS
Generic Name
Radiological PACS-dedicated management software
Model / Reference
NovaPACS 9.1.5
Primary DI / UDI-DI
B109NOVAPACS9150
510(k) Number
FDA Product Code
LLZ
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K171754)

Show all (12)

Other devices from Novarad Corporation

See all devices from Novarad Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Manufacturing Date: No