# K913471: Cirrus Gamma Camera

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Oct 23, 1991 after 79 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 4, 2013 · Class II · Z-0785-2014: The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies

Source page: https://510kreport.com/device/K913471
Methodology: https://510kreport.com/methodology