# K082354: Stereo Navigator Accessory, STN-1000

- Pathway: 510(k) (Traditional)
- Applicant: Naviscan Pet Systems
- Decided: Nov 18, 2008 after 95 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) Stereotactic Localization Device (SLD): named in the summary without a submission number
- (no number) Confirma Breast MRI Interventional Components: named in the summary without a submission number
- (no number) SureLoc® CADstream 4.0 System: named in the summary without a submission number

## Indications for use
The Stereo Navigator Accessory is an optional accessory to the PEM Flex ® PET Scanner. It is intended for the localization of lesions in female breasts, as identified on a PET image. By using the Stereo Navigator, the physician is able to guide compatible interventional devices towards the PET abnormality as medically indicated. The Stereo Navigator also provides a means to confirm localization of the lesion in advance of the interventional procedure.

Source page: https://510kreport.com/device/K082354
Methodology: https://510kreport.com/methodology