Schoelly Imaging, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Schoelly Imaging, Inc. makes
Schoelly Imaging, Inc. manufactures endoscopic illumination and imaging systems, including the VS-100 system, as well as flexible and rigid endoscopes such as the naso-laryngo-pharyngoscope, Flexiscopes (50MH and 50 MHC), and the Flexilux II cystoscope and hysteroscope.
These devices are classified under FDA regulations as Class I and Class II, with some models listed via the 510(k) pathway. The company’s products are intended for diagnostic and procedural use in medical imaging and endoscopy.
Catalogue
Vs-100 Illumination And Imaging System Ref K090800
Regimes: 510(k) Registry: 510(k)Naso-Laryngo-Pharyngoscope Ref K083553
Regimes: 510(k) Registry: 510(k)Fsc 2 Ref K090601
Regimes: 510(k) Registry: 510(k)Flexiscope, Models 50MH And 50 Mhc Ref K053412
Regimes: 510(k) Registry: 510(k)Flexilux Ii Cystoscope And Hysteroscope Ref K060899
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Schoelly Imaging, Inc. have in the registry?
The registry currently lists 5 devices for Schoelly Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Schoelly Imaging, Inc.'s devices?
Among its 5 most recently registered devices, Schoelly Imaging, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Schoelly Imaging, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Schoelly Imaging, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Schoelly Imaging, Inc. in the registry?
The most recently registered devices listed for Schoelly Imaging, Inc. include VS-100 ILLUMINATION AND IMAGING SYSTEM, NASO-LARYNGO-PHARYNGOSCOPE, FSC 2 and FLEXISCOPE, MODELS 50MH AND 50 MHC.