# K040668: E-Z Scan AB5500+

- Pathway: 510(k) (Special)
- Applicant: Sonomed, Inc.
- Decided: Apr 13, 2004 after 29 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 K843696 (1985). 2 ancestors in all.
76 later devices descend from it; 4 cite it directly.
1 of 79 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844031: Sonomed Tech Ophthalmic B-Scan B-3000, Sonomed Technology, Inc. (1985) Summary page 1.
- K843696: Ophthalmic a-Scan a-2000  Sonome, Sonomed Technology, Inc. (1985) Summary page 1.

## Most influential descendants
- K042467: Lso Pet/CT Hirez 64 (2004), 67 descendants of its own
- K050509: Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I (2005), 66 descendants of its own
- K060060: Biograph 6 (2006), 65 descendants of its own
- K060631: Biograph 64 and Biograph 40 (2006), 64 descendants of its own
- K081453: Biograph HD Family (2008), 62 descendants of its own

## Indications for use
The E-Z scan AB 5500+ ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power. The Intended Use of the A-Mode probe for the E-Z scan AB 5500+ ultrasound system is to make measurements inside the eye, including the measurement of axial length for determination of IOL power, and to visualize the eye by means of A-scans. The intended use of the B-Mode probe for the E-Z scan AB 5500 is to visualize the interior of the eye by means of ultrasound and to make measurements inside the eye by B-scan ultrasound.

Source page: https://510kreport.com/device/K040668
Methodology: https://510kreport.com/methodology