Digitec Medical Service Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Digitec Medical Service Corp. makes
Digitec Medical Service Corp. manufactures mammography equipment, including a two-stage compression kit designed for use with mammographic imaging systems. The compression kit aids in positioning and compressing breast tissue during imaging to improve diagnostic accuracy.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance for market authorisation. The devices are listed in the FDA’s 510(k) premarket notification database. The manufacturer is based in the United States.
Catalogue
Mammograph Ref K010792
Regimes: 510(k) Registry: 510(k)Digitec Two Stage Compression Kit Ref K993681
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Digitec Medical Service Corp. have in the registry?
The registry currently lists 2 devices for Digitec Medical Service Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Digitec Medical Service Corp.'s devices?
Among its 2 most recently registered devices, Digitec Medical Service Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Digitec Medical Service Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Digitec Medical Service Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Digitec Medical Service Corp. in the registry?
The most recently registered devices listed for Digitec Medical Service Corp. include MAMMOGRAPH and DIGITEC TWO STAGE COMPRESSION KIT.