OMB Individually Reported

AGFA DR 800 with MUSICA Dynamic

High riskExact public inventory row

Description

It can accelerate X-ray workflows. The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are similar to those previously cleared and used in Agfa’s radiography portfolio today which includes the DR 600 (K152639) and DR 400 (K141192). The addition of the dynamic image processing is identical to the predicate device (K140380).

Detailed example

Recommendations for image processing settings.

AI / analytics pattern

Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

Automation level / stage

c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

Expected benefit

Accelerate X-Ray workflows.

Controls / human review

ATO: Not reported; PIA: Not published