# K160933: Discovery NM 750b Bopsy

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Nov 18, 2016 after 228 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: 5 generations back to K952674 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102231: Discovery NM 750B, Ge Medical Systems Israel, Functional Imaging (2010) Summary page 4.
- K082588: Gammaloc System, Model 03-00001, Dilon Technologies, LLC (2009) Summary page 4.

## 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. When used with the optional Discovery NM 750b Biopsy system, the Discovery NM 750b is designed to accurately locate, in three dimensions, lesions in the breast using information derived from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes such as biopsy and pre-surgical localization.

Source page: https://510kreport.com/device/K160933
Methodology: https://510kreport.com/methodology