Health Images, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Health Images, Inc. makes
Health Images, Inc. manufactures MRI imaging systems and related diagnostic devices, including the HI-STAR MRI Imaging System, the HI-STANDARD Magnetic Resonance Diagnostic Device, and its upgrade kits. These products are designed for magnetic resonance imaging applications in clinical settings.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices. The devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Hi-Star Mri Imaging System Ref K964778
Regimes: 510(k) Registry: 510(k)Health Images, Inc. Hi-Standard Ref K944228
Regimes: 510(k) Registry: 510(k)Hi Standard Magnetic Resonance Diagnostic Device Ref K890092
Regimes: 510(k) Registry: 510(k)Health Image Inc. Hi Star Ref K944724
Regimes: 510(k) Registry: 510(k)H.i.standard Calibre Upgrade Ref K911746
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Health Images, Inc. have in the registry?
The registry currently lists 5 devices for Health Images, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Health Images, Inc.'s devices?
Among its 5 most recently registered devices, Health Images, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Health Images, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Health Images, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Health Images, Inc. in the registry?
The most recently registered devices listed for Health Images, Inc. include HI-STAR MRI IMAGING SYSTEM, HEALTH IMAGES, INC. HI-STANDARD, HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE and HEALTH IMAGE INC. HI STAR.