# K993813: Lumagem Scintillation Camera

- Pathway: 510(k) (Traditional)
- Applicant: Gamma Medica
- Decided: Jan 18, 2000 after 69 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.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921296: ADAC S315, Adac Laboratories (1992) Summary page 2.
- K961104: Notebook Imager, Digirad Corp. (1997) Summary page 2.
- K885054: System Seventy Seven, Scinticor, Inc. (1989) Summary page 2.
- (no number) Elscint APEX SPX-4: named in the summary without a submission number
- (no number) Siemens Orbiter: named in the summary without a submission number

## Most influential descendants
- K102231: Discovery NM 750B (2010), 3 descendants of its own
- K111791: Lumagem Molecular Breast Imaging System (2011), 1 descendant of its own
- K160933: Discovery NM 750b Bopsy (2016), 0 descendants of its own
- K123408: Ergo Imaging System (2013), 0 descendants of its own
- K092471: Model Sentinella 102 (2009), 0 descendants of its own

## Indications for use
The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted by qualified medical personnel.

Source page: https://510kreport.com/device/K993813
Methodology: https://510kreport.com/methodology