# K982855: Digirad 2020TC Spect Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Digirad Corp.
- Decided: Nov 4, 1998 after 90 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 K885054 (1989). 2 ancestors in all.
381 later devices descend from it; 7 cite it directly.
1 of 384 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885054: System Seventy Seven, Scinticor, Inc. (1989) Summary page 1.
- K953255: Nuquest Nuclear Medicine Computer, Sitco, Inc. (1995) Summary page 1.

## Most influential descendants
- K011572: Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) (2001), 354 descendants of its own
- K052379: Mim 3.5 (Circa) (2005), 353 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own

## Indications for use
The Digirad 2020¢c SPECT Imaging System is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in Nuclear Medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020¢c Imager™ to obtain SPECT images in patients who are seated in an upright position. Specifically, the 2020¢c Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

Source page: https://510kreport.com/device/K982855
Methodology: https://510kreport.com/methodology