# K970128: Isocam I (Single Head Gamma Camera)/Isocam II (Dual Head Gamma Camera)

- Pathway: 510(k) (Traditional)
- Applicant: Park Medical Systems, Inc.
- Decided: Apr 11, 1997 after 87 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Dyna camera 2 series high energy collimators: named in the summary without a submission number

## Most influential descendants
- K081757: Verista Imaging Isocam II Gamma Camera (2008), 0 descendants of its own

## Indications for use
The intended use of the Dyna Camera 2 series collimator is to detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body.

Source page: https://510kreport.com/device/K970128
Methodology: https://510kreport.com/methodology