# K213070: MD-320W Ultrasound Biomicroscope

- Pathway: 510(k) (Traditional)
- Applicant: MEDA Co., Ltd.
- Decided: Nov 18, 2021 after 56 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: 3 generations back to K843696 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140199: VUPAD, Sonomed, Inc. (2014) Summary page 4.

## Indications for use
MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes. The device is intended to be used in hospitals and ophthalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation. It is not allowed to use UBM on patients with eye trauma, inflammation or infection.

Source page: https://510kreport.com/device/K213070
Methodology: https://510kreport.com/methodology