510(k) · Cleared
Recalled · 2009Hitachi Presto
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 21, 2004 as substantially equivalent to K014240 (Hitachi Medical Systems America, Inc., 2002) after a 14-day review. Its family tree reaches back 5 generations to 1995. 15 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 21, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944131 (1995). 8 ancestors in all, the oldest K920950 (1992). 15 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 4 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 3 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 2 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 1 generation backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- This deviceK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004
- Descendant · cites it directly · 12 of its ownK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · 3 generations on · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- Descendant · 4 generations on · 2 of its ownK213649 BodyTom 64Neurologica Corporation · 2022
- Descendant · 3 generations on · 2 of its ownK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · cites it directly12descendants
- K102677Bodytom NL 4000Neurologica Corporation · 2011 · 2 generations on9descendants
- K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · 3 generations on4descendants
- K213649BodyTom 64Neurologica Corporation · 2022 · 4 generations on2descendants
- K131431Airo CT SystemMobius Imaging, LLC · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −4 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −3 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −2 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −1 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| 0 (this device) | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | — |
| +1 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| +2 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +3 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
| +4 | K213649 | BodyTom 64 | Neurologica Corporation | 2022 | — |
| +3 | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K014240 | ProntoSummary page 1…ame: System, X-Ray, Tomography, Computed Classification Number: Sec. 892.1750 Predicate Device Predicate Device: Hitachi Pronto CT, 510(k) K014240 @2004 Hitachi Medical Systems America, Inc. Presto CT Section 2… | 2002 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2009 | Not classified | Z-1651-2009 | Software design | Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale… |
| Nov 5, 2008 | Not classified | Z-0608-2009 | Software design | Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal). |
| Feb 21, 2006 | Not classified | Z-1078-06 | Other | The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them. |
| Feb 21, 2006 | Not classified | Z-1079-06 | Other | The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K071806 (Hitachi Medical Systems America, Inc., 2007) has gone furthest, with 12 descendants of its own.
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?
The Presto Computed Tomography system is an x-ray imaging device that produces cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040902: Hitachi Presto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040902
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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