Dianon Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dianon Systems, Inc. makes
Dianon Systems, Inc. manufactures fine needle aspiration biopsy systems, including specialized versions for prostate tissue sampling. These devices are designed for minimally invasive diagnostic procedures to obtain tissue samples for pathological examination.
The company’s products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records. The manufacturer is based in the United States.
Catalogue
Code #D2020-Fine Needle Aspiration Biopsy System Ref K882105
Regimes: 510(k) Registry: 510(k)Fine Needle Aspiration Biopsy System-Prostate Ref K872597
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dianon Systems, Inc. have in the registry?
The registry currently lists 2 devices for Dianon Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dianon Systems, Inc.'s devices?
Among its 2 most recently registered devices, Dianon Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dianon Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dianon Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dianon Systems, Inc. in the registry?
The most recently registered devices listed for Dianon Systems, Inc. include CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM and FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE.