# K960421: Sinuscan 102/Sinusprint

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Apr 16, 1997 after 443 days
- Product code: LWI (Ultrasound, Sinus)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874081 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874081: Enterscan, Pie Data Medical BV (1987) Summary page 1.

## Indications for use
The Oricla Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.

Source page: https://510kreport.com/device/K960421
Methodology: https://510kreport.com/methodology