# K963333: Optronics Epic Color Television Camera System (S97340)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Imaging, Inc.
- Decided: Oct 22, 1996 after 60 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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 its predicate without a number.
- (no number) Haag-Streit 900 BQ Slit Lamp: named in the summary without a submission number
- (no number) Haag-Streit 500 BM Slit Lamp: named in the summary without a submission number

## Most influential descendants
- K101861: Truevision 3D Visualization and Guidance System (2010), 13 descendants of its own
- K141068: Zeiss Cataract Suite Markerless (2014), 8 descendants of its own
- K123464: Callisto Eye (2013), 6 descendants of its own
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own
- K143275: IOLMaster700 (2015), 4 descendants of its own

## Indications for use
The Optronics EPIC System is intended for use as an accessory to a slit lamp biomicroscope, providing enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need.

Source page: https://510kreport.com/device/K963333
Methodology: https://510kreport.com/methodology