Bioimagene, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bioimagene, Inc. makes
Bioimagene, Inc. develops digital pathology software and systems for analyzing HER2/NEU, p53, and Ki-67 biomarkers in tissue samples. Their PATHIAM Imaging Software provides automated analysis for HER2/NEU expression, while the PATHIAM System with iScan integrates imaging and digital scanning for p53 and Ki-67 assessment. The company also supplies HER2/NEU immunohistochemistry reagents and kits designed for laboratory use.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are intended for use in the United States, where the company is based.
Catalogue
Pathiam Imaging Software For HER2/Neu Ref K062756
Regimes: 510(k) Registry: 510(k)Pathiam System With Iscan For P53 And Ki-67 Ref K092333
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioimagene, Inc. have in the registry?
The registry currently lists 3 devices for Bioimagene, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioimagene, Inc.'s devices?
Among its 3 most recently registered devices, Bioimagene, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bioimagene, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bioimagene, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioimagene, Inc. in the registry?
The most recently registered devices listed for Bioimagene, Inc. include PATHIAM IMAGING SOFTWARE FOR HER2/NEU, PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 and PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS.