Data / Medical devices / United States / Novarad Corp.
Novarad Corp.: FDA-registered device maker in Provo, UT, United States, 6 510(k) clearances
Novarad Corp. is registered with the FDA (registration 1721964) in Provo, UT, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 27, 2022. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1721964
- FEI number
- 1000117423
- Address
- 3152 North University Avenue Suite 200, Provo, UT, United States, 84604
- Owner or operator
- NOVARAD CORP. (9001638)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 25, 2012
- Registered through
- 2027
- Brand names listed
- Chameleon DR, CryptoChart, CryptoChart Lite, NovaDOSE, NovaMG, NovaPACS, NovaPACS EI, NovaPACS with Enterprise Imaging and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 27, 2022 | K220146 | VisAR | OLO | Substantially Equivalent | Novarad Corporation | accessdata.fda.gov |
| September 21, 2018 | K172418 | OpenSight | LLZ | Substantially Equivalent | Novarad Corporation | accessdata.fda.gov |
| July 28, 2017 | K171754 | NovaPACS | LLZ | Substantially Equivalent | Novarad Corporation | accessdata.fda.gov |
| October 23, 2014 | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | MQB | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| August 1, 2014 | K140551 | PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR | MQB | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| December 11, 2007 | K073272 | WORKSTATIONONE BREAST IMAGING WORKSTATION | LLZ | Substantially Equivalent | Three Palm Software, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 10, 2019 | 85347 | Class II | Terminated | NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA | 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. | accessdata.fda.gov |
| August 12, 2016 | 74937 | Class II | Terminated | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrie | Novarad 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. | accessdata.fda.gov |
| November 16, 2015 | 73977 | Class II | Terminated | NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation | The SUV values that are being calculated in the PET/CT fusion tool are incorrect. | accessdata.fda.gov |
| May 9, 2013 | 74556 | Class II | Terminated | NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) | Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Medical Device Data System
Updated May 27, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.