# K971980: MCD-AC

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Oct 23, 1997 after 147 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
Longest line of descent: 1 generation back to K952684 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952684: Vertex Epic MCD, Adac Laboratories (1995) Summary page 1.
- (no number) Vantage 1.0: named in the summary without a submission number
- (no number) UGM 240H: named in the summary without a submission number
- (no number) GE Advance: named in the summary without a submission number

## Most influential descendants
- 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

## Indications for use
ADAC MCD-AC option to ADAC Dual Head Emission Tomographic System produces images of biodistribution of positron-emitting radioisotopes previously administered to the human body. The system is intended to provide an enhancement to the emission images acquired using the ADAC MCD System by correcting for attenuation effects in the human body.

Source page: https://510kreport.com/device/K971980
Methodology: https://510kreport.com/methodology