# K922080: Genesys II

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Jul 17, 1992 after 74 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
1 of 19 devices in its family (counting itself) has 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.

## Most influential descendants
- K962738: Millennium MT and Millennium MG Nuclear Medicine Systems (1996), 16 descendants of its own
- K022240: Mobile Millennium MG System (2002), 11 descendants of its own
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K170238: BodyTom Elite (2017), 4 descendants of its own

## Recalls of this device
- Mar 13, 2015 · Class II · Z-1598-2015: During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body
- Mar 10, 2014 · Class II · Z-1510-2014: Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with

Source page: https://510kreport.com/device/K922080
Methodology: https://510kreport.com/methodology