# K123917: Declipsespect Viewer

- Pathway: 510(k) (Special)
- Applicant: Surgiceye GmbH
- Decided: Jan 25, 2013 after 37 days
- Product code: IZD (Probe, Uptake, Nuclear)
- Device class: 1
- Regulation: 21 CFR 892.1320
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
declipseSPECT Viwer works in conjuncion with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region, dedipseSPECT Viewer is intended to use the said detector and generate images of the distnibution of radionuclides in the human body and determine the 3D localization of these radioniuclides relative to surgical instruments by means of tracking technologies and image reconstruction techtniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing i-situ, such as SPECTICT and PET/CT_ declipseSPECT Viewer may also be used intraciperativelly or on pathological specimens if a protective cover is used to cover the nuclear uptake detector dedipseSPECT Viewer may be used at the patienit's bedside, or in an Emergency Room or Intensive Care Unit The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist anid physicians that ame trained to use the system. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel. declipseSPECT Viwr is compatible crrently tofdoMgncear upte detec.s Probe Manufacturer: Crystal Photonics; Probe Model: S003; Probe Model/Energy range of gamma rays: Gamma Probe CXS-OP-SZBN, 70 -245 key Probe Manufacturer: Crystal Photonics; Probe Model: S004; Probe Model/Energy range of gamma rays: Gamma Probe, CXS-OP-SP, 70 -245 keV Probe Manufacturer: Crystal Photonics; Probe Model: Beta; Probe Model/Energy range of gamma rays: Probe, CXS-OP-SB, 27 -30 keV Probe Manufacturer: RMD; Probe Model: Navigator; Probe Model/Energy range of gamma rays: Gamma Probe;, SP2A14, 27 -245 keV Probe Manufacturer: RMD; Probe Model: GPS; Probe Model/Energy range of gamma rays: curved; Gamma Probe;, SP2514, 27 - 245 key Probe Manufacturer: RMD; Probe Model: GPS; Probe Model/Energy range of gamma rays: straight; Gamma Probe;, SP2514, 27 - 245 key Probe Manufacturer: Eurorad; Probe Model: Europrobe 3; Probe Model/Energy range of gamma rays: Gamma Probe SOE31, 27 - 245 key

Source page: https://510kreport.com/device/K123917
Methodology: https://510kreport.com/methodology