# K072191: Clearvision Nuclear Medicine Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Gvi Technology Partners
- Decided: Oct 25, 2007 after 80 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: 5 generations back to K885054 (1989). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070542: Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems, Digirad Corp. (2007) Summary page 1.
- K023373: Onepass Nuclear Imaging System, Model 70-500101, Gvi Technology Partners (2003) Summary page 2.

## Indications for use
The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images. Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

Source page: https://510kreport.com/device/K072191
Methodology: https://510kreport.com/methodology