510(k) · Cleared
ClearedCT Biopsyview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 4, 1998 as substantially equivalent to K965004 (Siemens Medical Solutions USA, Inc., 1997) after a 57-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Nov 4, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K965004 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK965004 C.a.R.E. Vision for the Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc. · 1997
- This deviceK983140 CT BiopsyviewPhilips Medical Systems North America, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965004 | C.a.R.E. Vision for the Somatom Plus 4 CT Scanner | Siemens Medical Solutions USA, Inc. | 1997 | — |
| 0 (this device) | K983140 | CT Biopsyview | Philips Medical Systems North America, Inc. | 1998 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K950572 | Real-Time Reconstruction System option for the Toshiba Xpress/SX CT System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K965004 | C.a.R.E. Vision for the Somatom Plus 4 CT ScannerSummary page 2…Yotnts) ¢ Real-Time Reconstruction System option for the Toshiba Xpress/SX CT System (ref: K§50572; e C ARE. Vision option to the Siemens SOMOTOM Plus 4 CT System (ref: K965004) Each predicate device has been cleared for commercial distribution via its referenced 52« submission. SAFETY INFORMATION: The… | 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?
- Its one ancestor has no recall.
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 CT BiopsyView option is intended to be used for instant display of CT images during interventional procedures. The instant display of images allows the operating physician to watch the ptacement of an interventional instrument in real-time. CT BiopsyView is an option to the TOMOSCAN family of CT systems. TOMOSCAN systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional images of…
Read the full statement (199 words)
The CT BiopsyView option is intended to be used for instant display of CT images during interventional procedures. The instant display of images allows the operating physician to watch the ptacement of an interventional instrument in real-time.
CT BiopsyView is an option to the TOMOSCAN family of CT systems. TOMOSCAN 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.
The CT BiopsyView option extends the intended use of a TOMOSCAN CT system to include its use by a physician in the interventional 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/K983140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983140: CT Biopsyview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983140
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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