510(k) · Cleared
ClearedPinpoint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on May 20, 1998 after a 170-day review. The FDA summary names no predicate by number. 31 later devices descend from it.
- Decided
- May 20, 1998
- Review
- 170 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK974513 PinpointPhilips Medical Systems (Cleveland), Inc. · 1998
- Descendant · cites it directly · 27 of its ownK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- Descendant · 2 generations on · 16 of its ownK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- Descendant · 3 generations on · 11 of its ownK202297 Aline Ablation IntelligenceMirada Medical, Ltd. · 2020
- Descendant · cites it directly · 6 of its ownK131433 Isys 1 (U.S),Accessory, Non-SterileIsys Medizintechnik GmbH · 2014
- Descendant · 4 generations on · 4 of its ownK220256 MIM-AblationMim Software, Inc. · 2022
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K132108MAXIOPerfint Healthcare Pvt, Ltd. · 2014 · cites it directly27descendants
- K150313Ablation ConfirmationNeuwave Medical, Inc. · 2015 · 2 generations on16descendants
- K202297Aline Ablation IntelligenceMirada Medical, Ltd. · 2020 · 3 generations on11descendants
- K131433Isys 1 (U.S),Accessory, Non-SterileIsys Medizintechnik GmbH · 2014 · cites it directly6descendants
- K220256MIM-AblationMim Software, Inc. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974513 | Pinpoint | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| +1 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| +2 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| +3 | K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020 | — |
| +1 | K131433 | Isys 1 (U.S),Accessory, Non-Sterile | Isys Medizintechnik GmbH | 2014 | — |
| +4 | K220256 | MIM-Ablation | Mim Software, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (31)
See all 312 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132108 (Perfint Healthcare Pvt, Ltd., 2014) has gone furthest, with 27 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 PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat ‘panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer…
Read the full statement (170 words)
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat ‘panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
PinPoint is not limited to any particular region of the body. It is equally viable for planning head and spine interventions as it is in the abdomen. It is expected that its major use will be in the planning biopsies of abdominal organs and drainage of fluid collections in the abdomen. However, more complicated procedures such as Brachy therapy and bone pinnings will be planned using the PinPoint.
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/K974513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974513: Pinpoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974513
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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