# K964834: Isocam II (Dual Head Gamma Camera)

- Pathway: 510(k) (Traditional)
- Applicant: Park Medical Systems, Inc.
- Decided: Feb 28, 1997 after 88 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) ISOCAM II system: 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 “ISOCAM I manufactured by Park Medical Systems Inc. is a Single Photon Emission Computed Tomography (SPECT) gamma camera which is intended to image the distribution of radionuclides in the body by means of a single photon radiation detector. This system includes signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Source page: https://510kreport.com/device/K964834
Methodology: https://510kreport.com/methodology