Olicon Imaging Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Olicon Imaging Systems, Inc. makes
Olicon Imaging Systems, Inc. manufactures digital imaging systems, including the RAYTEL series, as well as proprietary software solutions like Gateway, 02-Workstation, and PACSVIEW for medical imaging workflows.
These products are classified as Class I devices under FDA regulations and are subject to 510(k) clearance requirements. The company is based in the United States.
Catalogue
Raytel Digital Imaging Systems Ref K922164
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Olicon Imaging Systems, Inc. have in the registry?
The registry currently lists 3 devices for Olicon Imaging Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Olicon Imaging Systems, Inc.'s devices?
Among its 3 most recently registered devices, Olicon Imaging Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Olicon Imaging Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Olicon Imaging Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Olicon Imaging Systems, Inc. in the registry?
The most recently registered devices listed for Olicon Imaging Systems, Inc. include RAYTEL DIGITAL IMAGING SYSTEMS, OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE and OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE.