# K923348: Ophthalmic a/B Scan System, Model 835 -- Modified

- Pathway: 510(k) (Traditional)
- Applicant: Zeiss Humphrey System
- Decided: Dec 10, 1992 after 196 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020151: UD-1000 Ultrasonic a/B Scanner (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K923348
Methodology: https://510kreport.com/methodology