# K152318: MD-2300S Ultrasonic A/B Scanner for Ophthalmology

- Pathway: 510(k) (Traditional)
- Applicant: MEDA Co., Ltd.
- Decided: Nov 17, 2015 after 92 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: 4 generations back to K913067 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051851: Aviso Ophthalmic Ultrasound System, Quantel Medical (2005) Summary page 7.
- K121243: Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter, MEDA Co., Ltd. (2013) Summary page 7.

## Indications for use
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement. The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure. The device should be operated by trained medical staff. Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients with keratitis and cornea trauma are prohibited from using A-Biometric scan. The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements.

Source page: https://510kreport.com/device/K152318
Methodology: https://510kreport.com/methodology