# K970369: Vista Mini Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Oktas
- Decided: Apr 14, 1997 after 73 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
Longest line of descent: 2 generations back to K923160 (1992). 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)
- K923160: 3DSCOPE, American Surgical Technologies Corp. (1992) Summary page 1.
- K961182: 3D Scope, Oktas (1996) Summary page 1.
- K946171: Video Endoscope System with Zoom, Oktas (1995) Summary page 1.
- K950985: Zeiss Endolive Stero Endoscope, Carl Zeiss, Inc. (1995). Our OCR of the scanned summary read K950988, FDA’s number for Holter 6000 (Omega Medical Services, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zeiss EndoLive™ Stereo Endoscope”.

## Indications for use
The device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.

Source page: https://510kreport.com/device/K970369
Methodology: https://510kreport.com/methodology