510(k) · Cleared
ClearedScatter Correction Volume Software Model NSSC-020A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba Medical Systems · KPS System, Tomography, Computed, Emission
Cleared on Dec 23, 1996 as substantially equivalent to K931297 (Toshiba America Medical Systems, In.C, 1993) after a 290-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Dec 23, 1996
- Review
- 290 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931297 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK931297 GCA-7200AToshiba America Medical Systems, In.C · 1993 · Recalled
- This deviceK960948 Scatter Correction Volume Software Model NSSC-020AToshiba Medical Systems · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931297 | GCA-7200A | Toshiba America Medical Systems, In.C | 1993 | 1 |
| 0 (this device) | K960948 | Scatter Correction Volume Software Model NSSC-020A | Toshiba Medical Systems | 1996 | — |
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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K931297 | GCA-7200ASummary page 1…a Cameras, Model NSSC-020A Common name: Gamma Camera Processing Software Classification name: Emission Computed Tomography System ® Predicate Device Toshiba GCA-7200A (K931297/A) ® Description of Device This product is an optional software program available for the Toshiba DI-series devices. It is inte… | 1993 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K931297.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
This program can be utilized for all traditional and accepted gamma camera applications. It is expected that its benefits will be realized primarily when the system is being used to acquire tomographic studies. The intended use of the gamma camera system is unchanged by this program. Toshiba believes that users will find the T.E.W method to be beneficial when performing dual-nuclide acquisitions, by enhancing the system’s ability to detect the energy…
Read the full statement (127 words)
This program can be utilized for all traditional and accepted gamma camera applications. It is expected that its benefits will be realized primarily when the system is being used to acquire tomographic studies. The intended use of the gamma camera system is unchanged by this program. Toshiba believes that users will find the T.E.W method to be beneficial when performing dual-nuclide acquisitions, by enhancing the system’s ability to detect the energy peaks of each nuclide without interference from the other nuclide. This determination is left to the user, however, and no specific claims regarding dual nuclide uses are being made. Due to the absence of new intended uses, it follows that the overall safety and effectiveness of the gamma camera system is not changed by this program.
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/K960948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960948: Scatter Correction Volume Software Model NSSC-020A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960948
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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