510(k) · Cleared
ClearedFlourospot T.O.P.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 31, 1996 as substantially equivalent to K914525 (Siemens Medical Solutions USA, Inc., 1991) and 2 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Jul 31, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914525 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K982028Fluorospot CompactSiemens Medical Solutions USA, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914525 | Flurospot H Version 2 | Siemens Medical Solutions USA, Inc. | 1991 | — |
| 0 (this device) | K961871 | Flourospot T.O.P. | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | K982028 | Fluorospot Compact | Siemens Medical Solutions USA, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 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.
Planning a device in LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K914525 | Flurospot H Version 2Summary page 3…e following medical devices currently in commercial distribution. P SIEMENS Model Company FDA K-Number Fluorospot T.O.P. Siemens Medical Systems, Inc. K914525 Polytron T.O.P. Siemens Medical Systems, Inc. K933664 QL MultiPulse 2048 InfiMed, Inc. K933299 Ly ftd S Lt /Kathleen ’Iiutherfoyd… | 1991 |
| * | K933664 | Polytron T.O.P. (Time, Operation, Performance)Summary page 3…stribution. P SIEMENS Model Company FDA K-Number Fluorospot T.O.P. Siemens Medical Systems, Inc. K914525 Polytron T.O.P. Siemens Medical Systems, Inc. K933664 QL MultiPulse 2048 InfiMed, Inc. K933299 Ly ftd S Lt /Kathleen ’Iiutherfoyd Dafe / Manager, Regulatory Submissions | 1993 |
| * | K933299 | QL Multipulse 2048Summary page 3…odel Company FDA K-Number Fluorospot T.O.P. Siemens Medical Systems, Inc. K914525 Polytron T.O.P. Siemens Medical Systems, Inc. K933664 QL MultiPulse 2048 InfiMed, Inc. K933299 Ly ftd S Lt /Kathleen ’Iiutherfoyd Dafe / Manager, Regulatory Submissions | 1993 |
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 |
|---|---|---|---|
| K982028 | Fluorospot Compact | 1998 | 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?
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The Fluorospot T.O.P. is intended for use with radiographic/fluoroscopic and universal interventional angiography x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot T.O.P. enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, digital tomographical exposures. urological examinations, vascular and non-vascular procedures as well as general angiography, interventional angiography, peripheral angiography and DSA (Digital Subtraction Angiography).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961871: Flourospot T.O.P..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961871
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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