# K043293: Mini-Gamma Camera, Models MGC500-101U and MGC500-301U

- Pathway: 510(k) (Special)
- Applicant: Acrorad Co., Ltd.
- Decided: Dec 17, 2004 after 18 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: 3 generations back to K885054 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040587: Mini Gamma Camera, Model MGC-500, Acrorad Co., Ltd. (2004) Summary page 1.

## Indications for use
The Mini Gamma Camera MGC500-101U and MGC500-301U are indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC500-101U and MGC500-301U may also be used intraoperatively if a protective sheath is used.

Source page: https://510kreport.com/device/K043293
Methodology: https://510kreport.com/methodology