# K983567: Image Technologies Stericam, Coupler-Drape and Troview Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Med Images, Inc.
- Decided: Jan 7, 1999 after 86 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K014158: Endoscopic Camera TC804/C4 (2002), 1 descendant of its own
- K032544: VP-1000; Med Cam 100; VP-3000A; Med Cam 300 (2003), 0 descendants of its own

## Indications for use
The Image Technologies Corporation SteriCam and TroView Imaging System consists of a CCD camera, coupler and a computer-based documentation system. The SteriCam is intended to attach to a standard commercially available endoscope for visualization of body cavities, hollow organs, and canals. The System includes a Coupler-Drape Assembly which is intended to couple the SteriCam to a standard commercially available endoscope. The TroView System is intended to provide documentation/storage of the image in the field of view of the SteriCam.

Source page: https://510kreport.com/device/K983567
Methodology: https://510kreport.com/methodology