Amicas, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Amicas, Inc. makes
Amicas, Inc. manufactures Picture Archiving and Communication Systems (PACS) for medical imaging, including the AMICAS LIGHT BEAM WORKSTATION and the AMICAS VISION SERIES PACS (versions 4.3 and 5.5). These systems are designed to store, retrieve, and display radiographic images, supporting radiology workflows in clinical settings.
The company’s PACS products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. The devices are intended for use in the United States, where Amicas, Inc. is based.
Catalogue
Amicas Light Beam Workstation, Model 1.0 Ref K022970
Regimes: 510(k) Registry: 510(k)Amicas Pacs, Version 6.0 Ref K082144
Regimes: 510(k) Registry: 510(k)Amicas Vision Series Pacs, Model 4.3 Ref K062477
Regimes: 510(k) Registry: 510(k)Amicas Vision Series Pacs, Model 5.5 Ref K073526
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amicas, Inc. have in the registry?
The registry currently lists 4 devices for Amicas, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amicas, Inc.'s devices?
Among its 4 most recently registered devices, Amicas, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Amicas, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Amicas, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amicas, Inc. in the registry?
The most recently registered devices listed for Amicas, Inc. include AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0, AMICAS PACS, VERSION 6.0, AMICAS VISION SERIES PACS, MODEL 4.3 and AMICAS VISION SERIES PACS, MODEL 5.5.