Sigma Biomedics, Inc.
Country not established
- Devices
- 1
What Sigma Biomedics, Inc. makes
Sigma Biomedics, Inc. manufactures the BIO-RAY SDX, a digital X-ray imaging system designed for medical diagnostics. This device provides radiographic imaging capabilities for clinical use, supporting real-time visualization of internal structures.
The BIO-RAY SDX is classified as a Class II medical device under FDA regulations and is recorded in the FDA’s 510(k) clearance database. The company is based in the United States.
Catalogue
Bio-Ray Sdx Digital X-Ray System Ref K060179
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sigma Biomedics, Inc. have in the registry?
The registry currently lists 1 device for Sigma Biomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sigma Biomedics, Inc.'s devices?
Among its 1 most recently registered device, Sigma Biomedics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Sigma Biomedics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sigma Biomedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sigma Biomedics, Inc. in the registry?
The most recently registered devices listed for Sigma Biomedics, Inc. include BIO-RAY SDX DIGITAL X-RAY SYSTEM.