# K013667: BCC Gamma Camera

- Pathway: 510(k) (Traditional)
- Applicant: Is2 Research, Inc.
- Decided: Jan 28, 2002 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NuCamma Bi90 camera: named in the summary without a submission number

## Indications for use
BREAST CANCER CAMERA IS INTENDED TO USE TO DETECT AND IMAGE THE DISTRIBUTION OF THE GAMMA EMITTING RADIONUCLIDE IN THE PATIENT'S BREAST AND SURROUNDING AREA AND TO STORE THE IMAGES WHEN THE RADIONUCLIDE IS ADMINISTERED TO THE PATIENT'S BODY.

Source page: https://510kreport.com/device/K013667
Methodology: https://510kreport.com/methodology