Aurora Imaging Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Aurora Imaging Technology, Inc. makes
Aurora Imaging Technology, Inc. manufactures magnetic resonance imaging (MRI) diagnostic devices, including standalone AURORA MRI systems and modifications to existing AURORA models. Their portfolio also includes an AURORA MR-guided interventional system designed for real-time MRI guidance during procedures.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Aurora Ref K032082
Regimes: 510(k) Registry: 510(k)Aurora Ref K003651
Regimes: 510(k) Registry: 510(k)Aurora Magnetic Resonance Diagnostic Device Ref K012154
Regimes: 510(k) Registry: 510(k)Modification To: Aurora Ref K052698
Regimes: 510(k) Registry: 510(k)Modification To: Aurora Ref K032678
Regimes: 510(k) Registry: 510(k)Aurora Mr-Guided Interventional System Ref K023686
Regimes: 510(k) Registry: 510(k)Modification To Aurora Mri System Ref K073425
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aurora Imaging Technology, Inc. have in the registry?
The registry currently lists 7 devices for Aurora Imaging Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aurora Imaging Technology, Inc.'s devices?
Among its 7 most recently registered devices, Aurora Imaging Technology, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Aurora Imaging Technology, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Aurora Imaging Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aurora Imaging Technology, Inc. in the registry?
The most recently registered devices listed for Aurora Imaging Technology, Inc. include AURORA, AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODIFICATION TO: AURORA and AURORA MR-GUIDED INTERVENTIONAL SYSTEM.