# K093706: Proxiscan Model 101

- Pathway: 510(k) (Traditional)
- Applicant: Hybridyne Imaging Technologies, Inc.
- Decided: Apr 2, 2010 after 122 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: 7 generations back to K935595 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022342: EZ-Scope an, EZ-Scope Light, Anzai Medical Co., Ltd. (2002) Summary page 1.
- K060879: Model EC9-4 Transducer, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.

## Indications for use
The ProxiScan" is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan~ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.

Source page: https://510kreport.com/device/K093706
Methodology: https://510kreport.com/methodology