# K063433: Ultrasonic Biometer/Pachymeter for Opthalmology Odm 2100 and Odm 2200

- Pathway: 510(k) (Traditional)
- Applicant: Meda, Ltd.
- Decided: Jan 29, 2007 after 77 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 K843696 (1985). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040668: E-Z Scan AB5500+, Sonomed, Inc. (2004) Summary page 1.

## Most influential descendants
- K222787: Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P (2023), 0 descendants of its own

## Indications for use
• Ultrasound Imaging of the eye • Axial biometric parameter measurement of the eye

Source page: https://510kreport.com/device/K063433
Methodology: https://510kreport.com/methodology