# K960043: Kodak Cardiology Digital Archive & Review System

- Pathway: 510(k) (Traditional)
- Applicant: Jamieson Film Co.
- Decided: Mar 27, 1996 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
145 later devices descend from it; 2 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K972229: Imageview Coronary Angiography Display and Review System (1997), 143 descendants of its own
- K994210: Inturis Suite (2000), 142 descendants of its own
- K022788: Philips Harmony Release 1 (2002), 129 descendants of its own
- K061995: Xcelera (2006), 128 descendants of its own
- K083348: Image-Arena Applications (2008), 89 descendants of its own

Source page: https://510kreport.com/device/K960043
Methodology: https://510kreport.com/methodology