Sitco, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Sitco, Inc. makes
Sitco, Inc. manufactures specialized medical imaging and diagnostic devices, including nuclear medicine computers for processing and analyzing imaging data, and biopsy tools like the BIOPSY-DIGIT and BIOPSY M for tissue sampling procedures. The company also produces the GIOTTO HT, a device used in gastrointestinal imaging.
These devices fall under FDA Class II regulation and are listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Nuquest Nuclear Medicine Computer Ref K953255
Regimes: 510(k) Registry: 510(k)Biopsy-Digit Ref K990192
Regimes: 510(k) Registry: 510(k)Biopsy M Ref K982049
Regimes: 510(k) Registry: 510(k)Giotto Ht Ref K973856
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sitco, Inc. have in the registry?
The registry currently lists 4 devices for Sitco, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sitco, Inc.'s devices?
Among its 4 most recently registered devices, Sitco, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Sitco, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sitco, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sitco, Inc. in the registry?
The most recently registered devices listed for Sitco, Inc. include NUQUEST NUCLEAR MEDICINE COMPUTER, BIOPSY-DIGIT, BIOPSY M and GIOTTO HT.