Gold Coast Imaging, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Gold Coast Imaging, Inc. makes
Gold Coast Imaging, Inc. manufactures the GIOTTO Patient Bed, a specialized medical bed designed for imaging procedures, and the CYTOGUIDE Stereotactic Biopsy System, used for precise tissue sampling under imaging guidance.
The company’s portfolio includes Class II devices, which are regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Giotto Patient Bed Ref K925212
Regimes: 510(k) Registry: 510(k)Cytoguide Stereotatic Biopsy System Ref K933430
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gold Coast Imaging, Inc. have in the registry?
The registry currently lists 2 devices for Gold Coast Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gold Coast Imaging, Inc.'s devices?
Among its 2 most recently registered devices, Gold Coast Imaging, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gold Coast Imaging, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gold Coast Imaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gold Coast Imaging, Inc. in the registry?
The most recently registered devices listed for Gold Coast Imaging, Inc. include GIOTTO PATIENT BED and CYTOGUIDE STEREOTATIC BIOPSY SYSTEM.