Insight Medbotics, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Insight Medbotics, Inc. makes
Insight Medbotics, Inc. manufactures the IGAR System, a medical imaging device designed for intraoperative guidance and real-time visualization during surgical procedures, particularly in orthopedic and spinal applications.
The IGAR System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
IGAR System (1001.A) Ref K223484
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Insight Medbotics, Inc. have in the registry?
The registry currently lists 1 device for Insight Medbotics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insight Medbotics, Inc.'s devices?
Among its 1 most recently registered device, Insight Medbotics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Insight Medbotics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Insight Medbotics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Insight Medbotics, Inc. in the registry?
The most recently registered devices listed for Insight Medbotics, Inc. include IGAR System (1001.A).