# K070943: B-Scan Plus

- Pathway: 510(k) (Traditional)
- Applicant: Accutome Ultrasound, Inc.
- Decided: Apr 19, 2007 after 15 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- 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: 2 generations back to K871536 (1987). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960765: Mentor Advent a/B System, Mentor Ophthalmics, Inc. (1996) Summary page 1.

## Most influential descendants
- K243227: B-Scan (2025), 0 descendants of its own
- K152573: 4Sight (2015), 0 descendants of its own
- K103471: Ubm Plus (2011), 0 descendants of its own

## Indications for use
The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.

Source page: https://510kreport.com/device/K070943
Methodology: https://510kreport.com/methodology