Accuimage Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Accuimage Diagnostics Corp. makes
Accuimage Diagnostics Corp. manufactures diagnostic imaging workstations and software tools, including upgrades for imaging gate systems and specialized software suites like AccuView and AccuAnalyze. Their portfolio also includes standalone devices such as AccuScope, AccuShade, AccuVRT, and AccuMIP, designed for medical imaging analysis. The company produces the PrimeLung device, which appears to be a dedicated imaging solution for pulmonary assessment.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database, indicating their regulatory pathway in the United States. The manufacturer is based in the US.
Catalogue
Accuimage Smartgate Upgrade Ref K012106
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Primelung Ref K024149
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accuimage Diagnostics Corp. have in the registry?
The registry currently lists 3 devices for Accuimage Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accuimage Diagnostics Corp.'s devices?
Among its 3 most recently registered devices, Accuimage Diagnostics Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Accuimage Diagnostics Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Accuimage Diagnostics Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accuimage Diagnostics Corp. in the registry?
The most recently registered devices listed for Accuimage Diagnostics Corp. include ACCUIMAGE SMARTGATE UPGRADE, ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP and PRIMELUNG.