# K991565: Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma Cameras and Vision Power Station Computer, for Use in S

- Pathway: 510(k) (Traditional)
- Applicant: Smv America
- Decided: Aug 2, 1999 after 89 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: 2 generations back to K952684 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952190: Transmission Attenuation Correction (Tac) Package, Sopha Medical Systems, Inc. (1996) Summary page 1.
- K971980: MCD-AC, Adac Laboratories (1997) Summary page 1.

## Indications for use
The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient’s anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option) . The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.

Source page: https://510kreport.com/device/K991565
Methodology: https://510kreport.com/methodology