O.M.I. Oncology Microsystems, Inc.
CanadaFDA 510(k) applicant, unverified
- Devices
- 2
What O.M.I. Oncology Microsystems, Inc. makes
O.M.I. Oncology Microsystems, Inc. manufactures the S9 Display System, a medical imaging device used for intraoperative visualization in surgical procedures, and the DVS (Option 01), a specialized imaging system designed for real-time diagnostic support during cancer treatments.
The company’s portfolio consists of Class II devices, regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) registry and are based in the United States.
Catalogue
S9 Display System Ref K874214
510(k) 510(k)Dvs (Option 01) Ref K883101
510(k) 510(k)
Frequently asked questions
How many devices does O.M.I. Oncology Microsystems, Inc. have in the registry?
The registry currently lists 2 devices for O.M.I. Oncology Microsystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list O.M.I. Oncology Microsystems, Inc.'s devices?
Among its 2 most recently registered devices, O.M.I. Oncology Microsystems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do O.M.I. Oncology Microsystems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for O.M.I. Oncology Microsystems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from O.M.I. Oncology Microsystems, Inc. in the registry?
The most recently registered devices listed for O.M.I. Oncology Microsystems, Inc. include S9 DISPLAY SYSTEM and DVS (OPTION 01).