# K051402: Onepass Nuclear Medicine Imaging System

- Pathway: 510(k) (Special)
- Applicant: Gvi Technology Partners
- Decided: Jun 13, 2005 after 13 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- 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 K931193 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023373: Onepass Nuclear Imaging System, Model 70-500101, Gvi Technology Partners (2003) Summary page 1.

## Indications for use
The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system. The OnePass system's design is optimized for acquiring and processing cardiac first pass data. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.

Source page: https://510kreport.com/device/K051402
Methodology: https://510kreport.com/methodology