510(k) · Cleared
ClearedSony Cine Video System Sme-3500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sony Medical Electronics Co. · IZI System, X-Ray, Angiographic
Cleared on Oct 17, 1990 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Oct 17, 1990
- Review
- 19 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK904447 Sony Cine Video System Sme-3500Sony Medical Electronics Co. · 1990
- Descendant · cites it directly · 0 of its ownK971154 Multipics (ME-977)Merlin Engineering Works, Inc. · 1997
Most influential descendants
Showing 1 of 1 · See all- K971154Multipics (ME-977)Merlin Engineering Works, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904447 | Sony Cine Video System Sme-3500 | Sony Medical Electronics Co. | 1990 | — |
| +1 | K971154 | Multipics (ME-977) | Merlin Engineering Works, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971154 | Multipics (ME-977) | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971154 (Merlin Engineering Works, Inc., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K904447 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904447: Sony Cine Video System Sme-3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904447
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026