# K103471: Ubm Plus

- Pathway: 510(k) (Traditional)
- Applicant: Accutome, Inc.
- Decided: Mar 14, 2011 after 110 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960622 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070943: B-Scan Plus, Accutome Ultrasound, Inc. (2007) Summary page 1.
- K092837: Oti-Scan 3000, Opko Instrumentation, Inc. (2009) Summary page 1.

## Indications for use
The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye.

Source page: https://510kreport.com/device/K103471
Methodology: https://510kreport.com/methodology