510(k) · Cleared
ClearedShimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TX W/Fluro Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Medical Systems · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 21, 1999 as substantially equivalent to K955255 (Shimadzu Medical Systems, 1996) after a 153-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 21, 1999
- Review
- 153 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955255 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955255 Shimadzu Whole Body X-Ray CT Scanner SCT-7000TXShimadzu Medical Systems · 1996
- This deviceK984156 Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TX…Shimadzu Medical Systems · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955255 | Shimadzu Whole Body X-Ray CT Scanner SCT-7000TX | Shimadzu Medical Systems | 1996 | — |
| 0 (this device) | K984156 | Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TX W/Fluro Option | Shimadzu Medical Systems | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K955255 | Shimadzu Whole Body X-Ray CT Scanner SCT-7000TXSummary page 2…lations. As mentioned at “Intended Use” in this clearance letter, the intended use of the SCT-7000TX W/FLUORO OPTION is the same as that of predicate device SCT-7000TX (K955255) except optional CT fluoroscopy . Consequently, the indications for use of the SCT-7000TX W/FLUORO OPTION " are.also the same as… | 1996 |
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 no recall.
- 3 other devices also cite its predicate K955255.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
This device is intended to be used in the examination of the whole body.
This device is used optionally in CT Fluoroscopy.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984156: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TX W/Fluro Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984156
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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