510(k) · Cleared
ClearedSafeCT-29
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medic Vision Imaging Solutions · JAK System, X-Ray, Tomography, Computed
Cleared on May 17, 2016 as substantially equivalent to K143400 (Siemens Medical Solutions USA, Inc., 2015) after a 180-day review. Its family tree reaches back 7 generations to 1998. 1 later device descends from it.
- Decided
- May 17, 2016
- Review
- 180 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K982349 (1998). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 6 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 3 generations backK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
- 1 generation backK143400 SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- This deviceK153331 SafeCT-29Medic Vision Imaging Solutions · 2016
- Descendant · cites it directly · 0 of its ownK170273 Z-DOSE29Zetta Medical Technologies, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K170273Z-DOSE29Zetta Medical Technologies, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −6 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| −5 | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | 5 |
| −4 | K081022 | Somatom Definition, Model as/as+ | Siemens Medical Solutions USA, Inc. | 2008 | 3 |
| −3 | K103127 | Somatom Definition as | Siemens Medical Solutions USA, Inc. | 2011 | 6 |
| −2 | K130901 | Somatom Definition as Open | Siemens Medical Systems, Inc. | 2014 | — |
| −1 | K143400 | SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | 2015 | 5 |
| 0 (this device) | K153331 | SafeCT-29 | Medic Vision Imaging Solutions | 2016 | — |
| +1 | K170273 | Z-DOSE29 | Zetta Medical Technologies, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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 |
|---|---|---|---|
| * | K143400 | SOMATOM Definition AS/AS+Summary page 4…n for 510(k) Submission: New Device Identification of the Legally Marketed Predicate Device Proprietary Name: syngo ® VA48 (SOMARIS/7 VA48) K143400 Regulation Number 892.1750 Product Code: JAK Committee/Panel: Radiology Device Class:… | 2015 |
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 |
|---|---|---|---|
| K170273 | Z-DOSE29 | 2017 | 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K170273 (Zetta Medical Technologies, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K143400.
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. 2016, this device’s year, is highlighted.
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?
The SafeCT-29 is intended for providing Computed Tomography Dose Check feature to Computed Tomography X-ray systems.
The SafeCT-29 is specifically indicated for providing the Computed Tomography Dose Check feature which notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose index is above the predefined thresholds, for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153331: SafeCT-29.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153331
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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