# K052610: Image Star II

- Pathway: 510(k) (Traditional)
- Applicant: Lakeshore Technologies, Inc.
- Decided: Nov 30, 2005 after 69 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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: 1 generation back to K952493 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952493: Fluorecord Model 762, Syracuse Scientific, Inc. (1995) Summary page 1.

## Indications for use
Lakeshore Technologies Inc., formally Syracuse Scientific Inc., intends to use its S§960 CCD TV camera in combination with its Image Star II digital image processor for the presentation of Fluoroscopic or Radiographic TV images as prescnted by the image intensifier of the X-ray system. A) The images may also be used to assist in operative procedures. B) This device is to be used in diagnostic radiology or cardiology. C) The clinical settings for this device are hospitals and /or medical centers. D) This device is to be used by a qualified radiologist or cardiologist.

Source page: https://510kreport.com/device/K052610
Methodology: https://510kreport.com/methodology