# K983088: Instacine D-2000

- Pathway: 510(k) (Special)
- Applicant: Fidelity Medical, Inc.
- Decided: Sep 22, 1998 after 25 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The InstaCine D-2000 system enables acquisition, display, electronic processing, storage and review of radiographic images generatced. during cercain medical procedures, particularly cardiac anglographic and radiographic/fluroscopic examinations. The product is intended primarily for on-line or remote viewing of cardiac catheterization angiography studies communigated by network, or trqnsporcted by CD~R interchange mediag which have been produced im accordaunce wich the ACC/NEMA DICOM& standard.

Source page: https://510kreport.com/device/K983088
Methodology: https://510kreport.com/methodology