Indications for Use

510(k) Number: K152977

Device Name: Ambra PACS

Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.

Ambra Viewer, a component of Ambra PACS, displays and manages diagnostic quality DICOM images.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.

Not intended for diagnostic use on mobile devices.

Prescription Use (Part 21 CFR 801 Subpart D).