# K053062: Cardiarc Spect Imaging Device, Model CQ103-RV2

- Pathway: 510(k) (Traditional)
- Applicant: Cardiarc, Ltd.
- Decided: Jan 6, 2006 after 67 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 K914350 (1991). 7 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982855: Digirad 2020TC Spect Imaging System, Digirad Corp. (1998) Summary page 1.
- K972886: Mirage, Segami Corp., Inc. (1997) Summary page 1.
- K010726: Modification to Mirage, Segami Corp., Inc. (2001) Summary page 1.

## Most influential descendants
- K062450: D-Spect Cardiac Scanner System (2006), 14 descendants of its own
- K072468: Modification to D-Spect Cardiac Scanner System (2007), 10 descendants of its own
- K110507: Cardiac Scanner and Processing System (2011), 9 descendants of its own
- K161740: D-SPECT Scanner, D-SPECT L Scanner (2016), 5 descendants of its own
- K180514: Veriton NM (2018), 4 descendants of its own

## Indications for use
The CARDIARC SPECT IMAGING DEVICE is intended for production of single photon emission computed tomography clinical images of the heart in nuclear medicine applications. CARDIARC SPECT IMAGING DEVICE produces images from the distribution of radioisotopes within the thorax, which are then interpreted by healthcare professionals to assess various anatomical structures and functions (e.g., blood flow to the heart).

Source page: https://510kreport.com/device/K053062
Methodology: https://510kreport.com/methodology