# K020151: UD-1000 Ultrasonic a/B Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corp. USA
- Decided: Apr 10, 2002 after 84 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: 1 generation back to K844686 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844686: Ophthascan B, Biophysic Medical, Inc. (1985) Summary page 1.
- K882162: Nidek US-3000, Nidek, Inc. (1988) Summary page 1.
- K923348: Ophthalmic a/B Scan System, Model 835 -- Modified, Zeiss Humphrey System (1992) Summary page 1.
- K003141: Ubm Plus, Model P45, Paradigm Medical Industries, Inc. (2000) Summary page 1.

## Indications for use
The UD-1000 A/B Scanner is indicated for: Ultrasound imaging of the eye and orbit Producing axial measurements of the eye Imaging the intraocular anatomy and pathology of the eye Imaging the anterior segment of the eye Imaging the anterior angle for Glaucoma Management Imaging of other structures of the anterior chamber

Source page: https://510kreport.com/device/K020151
Methodology: https://510kreport.com/methodology