510(k) · Cleared
ClearedLow Dose CT Lung Cancer Screening Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Healthcare Americas · JAK System, X-Ray, Tomography, Computed
Cleared on May 16, 2018 as substantially equivalent to K153444 (Philips Medical Systems (Cleveland), Inc., 2016) after a 40-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- May 16, 2018
- Review
- 40 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930090 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 4 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 3 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 1 generation backK153444 Philips Multislice CT System with Low Dose CT Lung CancerPhilips Medical Systems (Cleveland), Inc. · 2016
- This deviceK180901 Low Dose CT Lung Cancer Screening OptionHitachi Healthcare Americas · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −5 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −4 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −3 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −2 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −1 | K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | Philips Medical Systems (Cleveland), Inc. | 2016 | — |
| 0 (this device) | K180901 | Low Dose CT Lung Cancer Screening Option | Hitachi Healthcare Americas | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K153444 | Philips Multislice CT System with Low Dose CT Lung CancerSummary page 4…Radiology Predicate Device Name(s) Trade/Proprietary Name: Philips Multislice CT System with Low Dose CT Lung Cancer Screening K153444 (Philips Brillance CT 64-channel) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray s… | 2016 |
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 25 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 11 ancestors have a recall of any class.
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. 2018, 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 Low Dose CT Lung Cancer Screening Option for the SCENARIA and SUPRIA CT systems is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi. Some examples of published articles can be found at the American College of Radiology® (ACR) website: *…
Read the full statement (159 words)
The Low Dose CT Lung Cancer Screening Option for the SCENARIA and SUPRIA CT systems is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.
Some examples of published articles can be found at the American College of Radiology® (ACR) website:
* ACR-SCBT-MR-SPR Practice Parameter for the Performance of Thoracic Computed Tomography (CT) Res. 10 —2013
* ACR-STR Practice Parameter for the Performance and Reporting of Lung Cancer Screening Thoracic Computed Tomography (CT) Res. 4 — 2014
* Lung Cancer Screening Technical Specifications
* Lung Cancer Screening Resources
In addition, examples of published articles can be found at the American Association of Physicists Medicine (AAPM) website:
» Lung Cancer Screening CT Protocols Version 4.0, 02/23/16
* AAPM Report No. 96: The Measurement, Reporting, and Management of Radiation Dose in CT
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/K180901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180901: Low Dose CT Lung Cancer Screening Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180901
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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