510(k) · Cleared
ClearedPolytron T.O.P. (Time, Operation, Performance)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Gammasonics, Inc. · IZI System, X-Ray, Angiographic
Cleared on Dec 15, 1993 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 15, 1993
- Review
- 140 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK933664 Polytron T.O.P. (Time, Operation, Performance)Siemens Gammasonics, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK961871 Flourospot T.O.P.Siemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK991922 Digital Imaging System (BSR)Siemens Medical Solutions USA, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK982028 Fluorospot CompactSiemens Medical Solutions USA, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K961871Flourospot T.O.P.Siemens Medical Solutions USA, Inc. · 1996 · cites it directly1descendant
- K991922Digital Imaging System (BSR)Siemens Medical Solutions USA, Inc. · 1999 · cites it directly0descendants
- K982028Fluorospot CompactSiemens Medical Solutions USA, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933664 | Polytron T.O.P. (Time, Operation, Performance) | Siemens Gammasonics, Inc. | 1993 | — |
| +1 | K961871 | Flourospot T.O.P. | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | K991922 | Digital Imaging System (BSR) | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +2 | K982028 | Fluorospot Compact | Siemens Medical Solutions USA, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K961871 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 1 descendant 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/K933664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933664: Polytron T.O.P. (Time, Operation, Performance).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933664
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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