# K222998: F3

- Pathway: 510(k) (Traditional)
- Applicant: Acrew Imaging, Inc.
- Decided: Jun 20, 2023 after 265 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K913770 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160088: Cydar EV, Cydar, Ltd. (2016) Summary page 4.

## Indications for use
F3 provides image guidance by overlaying a previously constructed preoperative vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices. F3 is intended to assist fluoroscopy-guided endovascular procedures in the thorax. Suitable procedures include endovascular aortic aneurysm repair (AAA and mid-distal TAA) and angioplasty. F3 i not intended for use in the X-Ray guided procedures in the liver, kidneys or pelvic organs.

Source page: https://510kreport.com/device/K222998
Methodology: https://510kreport.com/methodology