# K092427: Spinal Guides Pacs (Pacs Medical Imaging Display Workstation)

- Pathway: 510(k) (Traditional)
- Applicant: Albert Davydov Dds PC Professional
- Decided: Mar 16, 2010 after 221 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010259 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063337: Opal-Rad, Viztek, Inc. (2006) Summary page 1.

## Indications for use
Spinal Guides PACS is intended to perform: operations relating to the acceptance of spinal X-ray medical images and patient demographic information, their display, digital processing, review and editing, measurements report generation with respective storage and teleradiology exchange capabilities. They are intended to be used by a physician to view the images and use as an aid in calculation of alteration of motion segment integrity (AOMSI) of human spine. This device is not intended to be used for mammography images and does not require usage of 5 Mega pixel monitors.

Source page: https://510kreport.com/device/K092427
Methodology: https://510kreport.com/methodology