# K042258: BP-Spect V1.O

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: Oct 4, 2004 after 45 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: 4 generations back to K954874 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020300: Northwestern Gated Blood Pool Spect (Numugas), Syntermed, Inc. (2002) Summary page 1.

## Indications for use
The BP-SPECTTM software program should be used for the display of wall motion and quantification of left and right ventricular function parameters from gated Tc99m blood pool SPECT studies.

Source page: https://510kreport.com/device/K042258
Methodology: https://510kreport.com/methodology