Novarad Corp.
Provo, UT, US
NOVARAD CORP. appears in FDA device records in Provo, UT. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Novarad Corp. between 2006 and 2022. The busiest year on record is 2006, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220146 | VisAR | OLO | Substantially Equivalent | |
| K172418 | OpenSight | LLZ | Substantially Equivalent | |
| K171754 | NovaPACS | LLZ | Substantially Equivalent | |
| K160371 | NovaPACS | LLZ | Substantially Equivalent | |
| K132853 | NOVAPACS | LLZ | Substantially Equivalent | |
| K063153 | NOVAPACS | LLZ | Substantially Equivalent | |
| K061920 | NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1721964 | 1000117423 | NOVARAD CORP. | 3152 North University Avenue Suite 200, Provo, UT 84604 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2956-2020 | 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. | Class II | Terminated | |
| Z-2659-2016 | 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 retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection fraction, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis. Images and data are stored on a digital archive with multiple redundancies; images and data are available on-site and offsite. Novarad provides all software, including third party software (i.e. Windows OS). NovaPACS software resides on third party hardware, which may vary depending on the client s PACS needs. All hardware is connected to the radiology department local area network. NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities. NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. NovaPACS is not intended for diagnostic image review on a mobile platform. While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application | 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. | Class II | Terminated | |
| Z-1613-2016 | 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. | Class II | Terminated | |
| Z-2151-2016 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain