NOVARAD CORP.
4 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (4)
- Inspections (1)
Devices registered here (1)
- Medical Device Data SystemProduct code OUG (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6310
Recalls & enforcement
- Class IITerminated2019-09-10The 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…
- Class IITerminated2016-08-12Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.
- Class IITerminated2015-11-16The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
- Class IITerminated2013-05-09Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
FDA inspections (1)
- VAI2016-03-30Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “NOVARAD CORP. (FEI 1000117423) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000117423-novarad-corp/
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