# K970605: 3-CCD Digital Camera

- Pathway: 510(k) (Traditional)
- Applicant: Envision Medical Corp.
- Decided: May 22, 1997 after 93 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.
125 later devices descend from it; 1 cites it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K941919: Oktas Endoscopy Video Camera System, Oktas (1994). Our OCR of the scanned summary read K941919, FDA’s number for Oktas Endoscopy Video Camera System (Oktas), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 1.

## Most influential descendants
- K031098: 3-CCD Digital Camera System (2003), 124 descendants of its own
- K063457: Truehd (1080P) Digital Camera System (2006), 116 descendants of its own
- K091515: Spy Scope Intra-Operative Operating System (2009), 106 descendants of its own
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100 (2011), 104 descendants of its own
- K124031: DA Vinci Fluorescence Imaging Vision System (2013), 103 descendants of its own

## Indications for use
The 3-CCD Digital Camera System provides medical professionals with video capabilities for diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K970605
Methodology: https://510kreport.com/methodology