# K955519: Analytical Review Station

- Pathway: 510(k) (Traditional)
- Applicant: Camtronics, Ltd.
- Decided: May 9, 1996 after 157 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934496 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941979: Video Plus with Analytical Workstation, Camtronics, Ltd. (1994) Summary page 1.
- K934496: X-Ray Angiographic System, Camtronics, Ltd. (1993) Summary page 1.

## Most influential descendants
- K992073: AX Workstation (1999), 0 descendants of its own

## Recalls of this device
- Jul 18, 2005 · Not classified · Z-1421-05: The potential exists for the AI1000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient imag

## Indications for use
This product is intended primarily for on-line or _re_mgtg!l_qwmg of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchage media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab su.gi;sl to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear-and ultrasound. The ARS?2 provides the capability to write and read CD-R optical discs which are produced in accordance w1th the ACC/NEMA DICOM standard.

Source page: https://510kreport.com/device/K955519
Methodology: https://510kreport.com/methodology