510(k) · Cleared
ClearedE-Z Scan AB5500+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonomed, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 13, 2004 as substantially equivalent to K844031 (Sonomed Technology, Inc., 1985) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1985. 1 of the 79 devices in its family, counting itself, has a Class I recall. 76 later devices descend from it.
- Decided
- Apr 13, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K843696 (1985). 2 ancestors in all. 76 later devices descend from it, 4 citing it directly. 1 of the 79 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK843696 Ophthalmic a-Scan a-2000 SonomeSonomed Technology, Inc. · 1985
- This deviceK040668 E-Z Scan AB5500+Sonomed, Inc. · 2004
- Descendant · cites it directly · 67 of its ownK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 66 of its ownK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- Descendant · 3 generations on · 65 of its ownK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- Descendant · 3 generations on · 64 of its ownK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 62 of its ownK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200213 Biograph mMR with syngo MR E11P-AP01 system…8 generations on · 2020
Most influential descendants
Showing 5 of 76 · See all- K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · cites it directly67descendants
- K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005 · 2 generations on66descendants
- K060060Biograph 6Siemens Medical Solutions USA, Inc. · 2006 · 3 generations on65descendants
- K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · 3 generations on64descendants
- K081453Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008 · 4 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843696 | Ophthalmic a-Scan a-2000 Sonome | Sonomed Technology, Inc. | 1985 | — |
| 0 (this device) | K040668 | E-Z Scan AB5500+ | Sonomed, Inc. | 2004 | — |
| +1 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| +2 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| +3 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +3 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +4 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 1 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K844031 | Sonomed Tech Ophthalmic B-Scan B-3000Summary page 1…ystem Classification Name: System, Imaging, Ultrasonic, Ophthalmic, 980IYO (3) Equivalent legally-marketed devices: 1. Sonomed Ophthalmic B-scan B-3000, K844031 2. Sonomed A-scan A-2000, K843696 (4) Description The E-Z Scan AB5500 + combines a contact B-scanner used for t… | 1985 |
| * | K843696 | Ophthalmic a-Scan a-2000 SonomeSummary page 1…Imaging, Ultrasonic, Ophthalmic, 980IYO (3) Equivalent legally-marketed devices: 1. Sonomed Ophthalmic B-scan B-3000, K844031 2. Sonomed A-scan A-2000, K843696 (4) Description The E-Z Scan AB5500 + combines a contact B-scanner used for the visualization by ultrasound of the eye… | 1985 |
What descends from it? (76)
See all 764 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K042467 (Cti Pet Systems, Inc., 2004) has gone furthest, with 67 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
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…
Read the full statement (124 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040668 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040668: E-Z Scan AB5500+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040668
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026