# K221711: AccuICAS

- Pathway: 510(k) (Traditional)
- Applicant: ArteryFlow Technology Co., Ltd.
- Decided: Feb 28, 2023 after 260 days
- Product code: QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device)
- 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: 17 generations back to K926514 (1993). 101 ancestors in all.
No later device cites it as a predicate yet.
1 of 102 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210093: AccuFFRangio, ArteryFlow Technology Co., Ltd. (2021) Summary page 4.

## Indications for use
AcculCAS is software intended to be used for performing calculations in X-ray angiographic images of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, Accul CAS provides: Quantitative results of intracranial vessel segments based on a 3D reconstructed model; Dimensions of the intracranial vessels and lesions; Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. AcculCAS is indicated for use in clinical settings where validated and reproducible quantitied results are needed to support the assessment of intracranial vessels in X-ray angiographic images. When the quantified results provided by Accul CAS are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

Source page: https://510kreport.com/device/K221711
Methodology: https://510kreport.com/methodology