# K082588: Gammaloc System, Model 03-00001

- Pathway: 510(k) (Traditional)
- Applicant: Dilon Technologies, LLC
- Decided: Dec 11, 2009 after 459 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: 2 generations back to K924639 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984466: Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5, Dilon Technologies, Inc. (1999) Summary page 1.

## Most influential descendants
- K160933: Discovery NM 750b Bopsy (2016), 0 descendants of its own

## Indications for use
The GammaLoc® System is a lesion localization accessory for the Dilon 6800 Gamma Camera. This stereotactic localization system gives the physician the capability to perform needle biopsy of lesions determined to be suspicious through gamma imaging.

Source page: https://510kreport.com/device/K082588
Methodology: https://510kreport.com/methodology