Precision AI Pty, Ltd.
AustraliaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Precision AI Pty, Ltd. makes
Precision AI Pty, Ltd. develops the Precision AI Surgical Planning System (PAI-SPS), a software-based tool designed for preoperative surgical planning and anatomical visualization in orthopedic and spinal procedures.
The PAI-SPS is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Precision AI Surgical Planning System (PAI-SPS) Ref K243955
Regimes: 510(k) Registry: 510(k)Precision AI Surgical Planning System (PAI-SPS) Ref K233992
Regimes: 510(k) Registry: 510(k)Precision AI Surgical Planning System (PAI-SPS) Ref K251558
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Precision Ai Pty Ltd Brisbane Queensland · AU FEI 3031914485
Frequently asked questions
How many devices does Precision AI Pty, Ltd. have in the registry?
The registry currently lists 3 devices for Precision AI Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Precision AI Pty, Ltd.'s devices?
Among its 3 most recently registered devices, Precision AI Pty, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Precision AI Pty, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Precision AI Pty, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Precision AI Pty, Ltd. in the registry?
The most recently registered devices listed for Precision AI Pty, Ltd. include Precision AI Surgical Planning System (PAI-SPS).
Which FDA establishments are linked to Precision AI Pty, Ltd.?
1 FDA establishment is linked to Precision AI Pty, Ltd. in the registry; they are listed on the company page.