510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Ultrasim CT System

K001088510(k) TraditionalCleared Jun 22, 200079-day reviewClass II21 CFR 892.1750Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 22, 2000 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 2 times.

Decided
Jun 22, 2000
Review
79 days
Class
Class II
Product code
JAK
Recalls
2
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2016: 1 descendant cleared2008: 1 descendant cleared2017: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared2018: 1 descendant cleared2026: 2 descendants cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK001088 Ultrasim CT SystemPhilips Medical Systems (Cleveland), Inc. · 2000
  2. Descendant · cites it directly · 10 of its ownK033357 Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 6 of its ownK171850 Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
  5. Descendant · 3 generations on · 1 of its ownK181797 Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc. · 2018
  6. Descendant · 2 generations on · 1 of its ownK160611 P-ArtisP-Cure, Ltd. · 2016

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12016: 12017: 12018: 12022: 12024: 12025: 22026: 2
2004high 2 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all
  • K033357Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. · 2004 · cites it directly10descendants
  • K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 2017 · 2 generations on6descendants
  • K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024 · 3 generations on3descendants
  • K181797Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc. · 2018 · 3 generations on1descendant
  • K160611P-ArtisP-Cure, Ltd. · 2016 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001088Ultrasim CT SystemPhilips Medical Systems (Cleveland), Inc.2000—
+1K033357Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc.200450
+2K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc.201714
+3K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd.2024—
+3K181797Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc.2018—
+2K160611P-ArtisP-Cure, Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
201610
201710
201810
202210
202410
202520
202620
FIG. 1 — Lineage of K001088, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033357Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc.200410

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 1, 2021Class IIZ-0277-2022Device DesignSignificant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in…
Mar 23, 2004Not classifiedZ-0958-05OtherSoftware anomaly in the DICOM Modality Worklist. When restoring a patient's images from the optical disk, images from the wrong patient may be displayed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033357 (Philips Medical Systems (Cleveland), Inc., 2004) has gone furthest, with 10 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

More from Philips Medical Systems (Cleveland)…

209 FDA decisions under this applicant name. See the company

  • K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 201714 recalls
  • K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc. · 20173 recalls
  • K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc. · 20176 recalls
  • K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 20172 recalls
  • K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 20173 recalls

Recent decisions in JAK

The JAK category page

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https://510kreport.com/device/K001088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001088: Ultrasim CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001088

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026