# K023373: Onepass Nuclear Imaging System, Model 70-500101

- Pathway: 510(k) (Traditional)
- Applicant: Gvi Technology Partners
- Decided: Jan 3, 2003 after 87 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931193 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931193: Sim-400 System, Scinticor, Inc. (1993) Summary page 1.

## Most influential descendants
- K072191: Clearvision Nuclear Medicine Imaging System (2007), 0 descendants of its own
- K051402: Onepass Nuclear Medicine Imaging System (2005), 0 descendants of its own

## Recalls of this device
- Jan 16, 2004 · Not classified · Z-0527-04: Due to limitations in the operating software, the acquired scan may not be processed properly.

## 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 lfootprint and small FOV detector are specifically designed for placement in a facility lacking adequate flooi 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/K023373
Methodology: https://510kreport.com/methodology