# K102231: Discovery NM 750B

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Israel, Functional Imaging
- Decided: Nov 3, 2010 after 86 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: 4 generations back to K952674 (1995). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022960: GE Quasar Nuclear Medicine System, Ge Medical Systems F.I. Haifa (2002) Summary page 1.
- K993813: Lumagem Scintillation Camera, Gamma Medica (2000) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.

Source page: https://510kreport.com/device/K102231
Methodology: https://510kreport.com/methodology