# K981291: Vantage 3.0 Insynch

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Jun 29, 1998 after 81 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
Longest line of descent: 2 generations back to K943596 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971878: Vantage 2.1 Exspect, Adac Laboratories (1997) Summary page 1.

## Indications for use
The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image

Source page: https://510kreport.com/device/K981291
Methodology: https://510kreport.com/methodology