# K243077: Affirm 800

- Pathway: 510(k) (Traditional)
- Applicant: Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- Decided: Jun 27, 2025 after 270 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K944261 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202391: DIR 800, Aesculap, Inc. (2021) Summary page 5.

## Indications for use
The Affirm 800 is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral vessel branch occlusion, as well as intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

Source page: https://510kreport.com/device/K243077
Methodology: https://510kreport.com/methodology