# K040587: Mini Gamma Camera, Model MGC-500

- Pathway: 510(k) (Traditional)
- Applicant: Acrorad Co., Ltd.
- Decided: May 14, 2004 after 70 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 K885054 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961104: Notebook Imager, Digirad Corp. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K971320: Cre Balloon Dilatation Catheter, Boston Scientific Corp (1997). Our reading of the summary gave K971320, FDA’s number for Cre Balloon Dilatation Catheter (Boston Scientific Corp). Its FDA name has none of the distinctive words the summary uses for the device it names, “Neoprobe 1500/2000 radioisotope detector”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K043293: Mini-Gamma Camera, Models MGC500-101U and MGC500-301U (2004), 0 descendants of its own

## Indications for use
The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.

Source page: https://510kreport.com/device/K040587
Methodology: https://510kreport.com/methodology