# K101887: Confident Surgery Suite 300, Model CSS300

- Pathway: 510(k) (Traditional)
- Applicant: Surgiceye GmbH
- Decided: Mar 22, 2011 after 259 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
Longest line of descent: 4 generations back to K942580 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971167: Neoprobe Model 1500 Portable Radioisotope Detector and Accessories, Neoprobe Corp. (1997) Summary page 1.
- K013751: Handheld Gamma Finder (HGF), Silicon Instruments Gmhb (2002) Summary page 1.
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 1.
- K091457: Nexstim Eximia Navigated Brain Stimulation System, Nexstim OY (2009) Summary page 1.

## Indications for use
Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. 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.

Source page: https://510kreport.com/device/K101887
Methodology: https://510kreport.com/methodology