# K960044: Ultramax/Model Number A1

- Pathway: 510(k) (Traditional)
- Applicant: Entlab OY
- Decided: Aug 2, 1996 after 213 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
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) Echosine Sinus Scanner: named in the summary without a submission number

## Indications for use
Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.

Source page: https://510kreport.com/device/K960044
Methodology: https://510kreport.com/methodology