# K952684: Vertex Epic MCD

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Nov 24, 1995 after 165 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971980: MCD-AC (1997), 2 descendants of its own
- K963273: Vcar Option to Vision FX-80 Gamma Camera and Power Station (1997), 1 descendant of its own
- K991565: Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma Cameras and Vision Power Station Computer, for Use in S (1999), 0 descendants of its own
- K991535: Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras (1999), 0 descendants of its own
- K972686: Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer (1997), 0 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/K952684
Methodology: https://510kreport.com/methodology