510(k) · Cleared
ClearedFluorospot Compact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jul 14, 1998 as substantially equivalent to K961871 (Siemens Medical Solutions USA, Inc., 1996) and 2 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 14, 1998
- Review
- 35 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K914525 (1991). 5 ancestors in all, the oldest K911082 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914525 | Flurospot H Version 2 | Siemens Medical Solutions USA, Inc. | 1991 | — |
| −1 | K961871 | Flourospot T.O.P. | Siemens Medical Solutions USA, Inc. | 1996 | — |
| 0 (this device) | K982028 | Fluorospot Compact | Siemens Medical Solutions USA, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | K961871 | Flourospot T.O.P.Summary page 1…evice Code: 90JAA 3. Substantial Equivalence: The Fluorospot Compact is substantially equivalent to the following Siemens Medical Systems’ devices: 1) Fluorospot T.O.P K961871, cleared by FDA on July 31, 1996 2) Fluorospot H (Version 2) K914525, cleared by FDA on November 19, 1991 Fluorospot H (Version… | 1996 |
| * | K914525 | Flurospot H Version 2Summary page 1…is substantially equivalent to the following Siemens Medical Systems’ devices: 1) Fluorospot T.O.P K961871, cleared by FDA on July 31, 1996 2) Fluorospot H (Version 2) K914525, cleared by FDA on November 19, 1991 Fluorospot H (Version 1) K911082, cleared by FDA on May 1, 1991 4, Device Description: The… | 1991 |
| * | K911082 | Real Time X-Ray Imaging SystemSummary page 1…evices: 1) Fluorospot T.O.P K961871, cleared by FDA on July 31, 1996 2) Fluorospot H (Version 2) K914525, cleared by FDA on November 19, 1991 Fluorospot H (Version 1) K911082, cleared by FDA on May 1, 1991 4, Device Description: The Fluorospot Compact is a PC-based, 10 bit acquisition digital imaging s… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.
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/K982028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982028: Fluorospot Compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982028
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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