510(k) · Cleared
ClearedPhilips Tomoscan CS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 6, 1998 as substantially equivalent to K944326 (Philips Medical Systems North America, Inc., 1994) and 2 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1995. 18 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K944131 (1995). 4 ancestors in all, the oldest K920950 (1992). 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 1 generation backK964890 Anatom 2000Analogic Corp. · 1997
- This deviceK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- Descendant · cites it directly · 17 of its ownK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- Descendant · 2 generations on · 16 of its ownK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- Descendant · 3 generations on · 15 of its ownK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 12 of its ownK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- Descendant · 5 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K991278Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999 · cites it directly17descendants
- K014240ProntoHitachi Medical Systems America, Inc. · 2002 · 2 generations on16descendants
- K040902Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · 3 generations on15descendants
- K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · 4 generations on12descendants
- K102677Bodytom NL 4000Neurologica Corporation · 2011 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −1 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| 0 (this device) | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| +1 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| +2 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| +3 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| +4 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| +5 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K944326 | Philips Tomoscan SR5000Summary page 1…at the scan plane. All scanning facilities and features of the TOMOSCAN CS are the same as with predicate devices TOMOSCAN AVP1 (previously named TOMOSCAN SR5000, ref: K944326) and TOMOSCAN EG (also named ANATOM 2000; ref: K964890). The viewing and image processing features of the predicate device EasyVi… | 1994 |
| * | K964890 | Anatom 2000Summary page 1…es of the TOMOSCAN CS are the same as with predicate devices TOMOSCAN AVP1 (previously named TOMOSCAN SR5000, ref: K944326) and TOMOSCAN EG (also named ANATOM 2000; ref: K964890). The viewing and image processing features of the predicate device EasyVision (ref: K920950) are integrated as part of the TOMOS… | 1997 |
| * | K920950 | Philips EasyvisionSummary page 1…TOMOSCAN SR5000, ref: K944326) and TOMOSCAN EG (also named ANATOM 2000; ref: K964890). The viewing and image processing features of the predicate device EasyVision (ref: K920950) are integrated as part of the TOMOSCAN CS system. INTENDED USE: The TOMOSCAN CS is a whole body Computed Tomography (CT) syste… | 1992 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991278 | Philips Tomoscan AV-NT | 1999 | 17 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K991278 (Philips Medical Systems North America, Inc., 1999) has gone furthest, with 17 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 TOMOSCAN CS is a whole body Computed Tomography (CT) system which is a diagnostic X-ray system 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. It 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…
Read the full statement (126 words)
The TOMOSCAN CS is a whole body Computed Tomography (CT) system which is a diagnostic X-ray system 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. It 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. It is used for the display, storage and analysis of digital diagnostic CT images. The TOMOSCAN CS is 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/K982631 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982631: Philips Tomoscan CS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982631
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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