510(k) · Cleared
ClearedDoseright
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 1, 2001 as substantially equivalent to K964746 (GE Medical Systems, 1997) after a 76-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Oct 1, 2001
- Review
- 76 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940606 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K964746 | Hispeed CT/I with Performix Tube and Warp Scan OptionSummary page 2…ion is considered comparable and substantially equivalent to the following predicate device. + SmartScan Option used in GE Medical System’s HiSpeed CT/i CT System (ref. K964746) The above-mentioned CT system has been cleared for commercial distribution via the referenced 510(k) submission. SAFETY INFORM… | 1997 |
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 2 companies; a new generation was cleared every 4.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K964746.
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?
DoseRight is intended to be used for automatic dose regulation during CT scanning for the purpose of obtaining the desired image quality at the lowest possible dose. DoseRight is a software option to the CT Vision family of CT systems. These systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same…
Read the full statement (161 words)
DoseRight is intended to be used for automatic dose regulation during CT scanning for the
purpose of obtaining the desired image quality at the lowest possible dose.
DoseRight is a software option to the CT Vision family of CT systems. These systems are whole
body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to
produce cross-sectional images of the body by computer reconstruction of x-ray transmission of
data from the same axial plane taken at different angles. They includes signal analysis and
display equipment, patient and equipment supports, component parts and accessories which are
used in combination with signal and image processing software to facilitate the relative localization
of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices
with or without contrast mediums. They are used for the display, storage and analysis of digital
diagnostic CT images. They are intended for use by a physician in the diagnosis and planning
phases of patient conditions and treatment.
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/K012238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012238: Doseright.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012238
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026