510(k) Report

510(k) · Cleared

Cleared

Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool

K092747510(k) TraditionalCleared Oct 9, 200931-day reviewClass II21 CFR 892.1750

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 Oct 9, 2009 as substantially equivalent to K042293 (Philips Medical Systems (Cleveland), Inc., 2004) and 5 other predicates after a 31-day review. Its family tree reaches back 9 generations to 1991. 19 later devices descend from it.

Decided
Oct 9, 2009
Review
31 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
6

Its longest line of descent runs back 9 generations to K913770 (1991). 63 ancestors in all, the oldest K871859 (1987). 19 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 2 other ancestors2006: 2 other ancestors2004: 4 other ancestors2005: 1 other ancestor2003: 2 other ancestors2002: 5 other ancestors2001: 7 other ancestors1999: 4 other ancestors2000: 3 other ancestors1998: 4 other ancestors1997: 4 other ancestors1995: 3 other ancestors1993: 3 other ancestors1996: 5 other ancestors1994: 4 other ancestors1987: 1 other ancestor2024: 2 descendants cleared2012: 1 descendant cleared2022: 1 descendant cleared2025: 7 descendants cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 5 descendants cleared2020: 1 descendant clearedK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002×2: 2 generations cleared close together, K032748 (2003), K040305 (2004) K043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalledK052632 · VITREA2 Version 3.8 Medical Image Processing Software · Vital Images, Inc. · 2005 · recalledK061624 · Vitrea, Version 3.9 · Vital Images, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 12 other ancestors3 generations back: 11 other ancestors4 generations back: 12 other ancestors5 generations back: 7 other ancestors6 generations back: 3 other ancestors7 generations back: 3 other ancestors8 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants K061624 · Vitrea, Version 3.9 · Vital Images, Inc. · 2006 · recalledK052632 · VITREA2 Version 3.8 Medical Image Processing Software · Vital Images, Inc. · 2005 · recalledK043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalledK040305 · VITREA2 Version 3.5 · Vital Images, Inc. · 2004K032748 · VITREA2, Version 3.4 Medical Image Processing Software · Vital Images, Inc. · 2003 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991−50+5
  1. Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 5 generations between
  3. 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  4. 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
  5. 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
  6. This deviceK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
  7. Descendant · cites it directly · 16 of its ownK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
  8. Descendant · 2 generations on · 7 of its ownK190868 Cleerly LabsCleerly, Inc. · 2019
  9. Descendant · 3 generations on · 5 of its ownK202280 Cleerly Labs v2.0Cleerly, Inc. · 2020
  10. Descendant · 2 generations on · 3 of its ownK212758 AutoplaqueCedars-Sinai Medical Center: Aim · 2023
  11. Descendant · 4 generations on · 2 of its ownK242338 Cleerly LABS (v2.0)Cleerly, Inc. · 2025
Show all 9 generations
  1. Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. 6 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
  5. 5 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  6. 4 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  7. 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  8. 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
  9. 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
  10. This deviceK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2012: 12019: 12020: 12022: 12023: 12024: 22025: 72026: 5
2012high 7 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 19 · See all
  • K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012 · cites it directly16descendants
  • K190868Cleerly LabsCleerly, Inc. · 2019 · 2 generations on7descendants
  • K202280Cleerly Labs v2.0Cleerly, Inc. · 2020 · 3 generations on5descendants
  • K212758AutoplaqueCedars-Sinai Medical Center: Aim · 2023 · 2 generations on3descendants
  • K242338Cleerly LABS (v2.0)Cleerly, Inc. · 2025 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−8K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−7K020483Advantage Workstation 4.1GE Medical Systems20022
−6K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002—
−5K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20032
−4K040305VITREA2 Version 3.5Vital Images, Inc.2004—
−3K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041
−2K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20052
−1K061624Vitrea, Version 3.9Vital Images, Inc.20061
0 (this device)K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.2009—
+1K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.2012—
+2K190868Cleerly LabsCleerly, Inc.2019—
+3K202280Cleerly Labs v2.0Cleerly, Inc.2020—
+2K212758AutoplaqueCedars-Sinai Medical Center: Aim2023—
+4K242338Cleerly LABS (v2.0)Cleerly, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199330
199440
199530
199650
199740
199840
199940
200030
200170
200250
200320
200440
200510
200620
200720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201910
202010
202210
202310
202420
202570
202650
FIG. 1 — Lineage of K092747, 1991–2026Source: 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), 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. #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
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042293Brilliance CT, Private Practice CV Configuration, CT Scanner
Summary page 1
…ly in commercial distribution, namely: * Philips Medical Systemrs (Cleveland), Inc., Brilliance CT, Private Practice CV Configuration, K042293 * Shina Systems Ltd., CardioCT, K070226 * GE- CardlQ Fusion, K06 1370 * GE - Advanced Vess…
Philips Medical Systems (Cleveland), Inc.20041
*K070226Cardioct
Summary page 1
…* Philips Medical Systemrs (Cleveland), Inc., Brilliance CT, Private Practice CV Configuration, K042293 * Shina Systems Ltd., CardioCT, K070226 * GE- CardlQ Fusion, K06 1370 * GE - Advanced Vessel Analysis LI, K060779 * Vital Imaging…
Shina Systems, Ltd.2007—
*K061370Cardiq Fusion
Summary page 1
…, Inc., Brilliance CT, Private Practice CV Configuration, K042293 * Shina Systems Ltd., CardioCT, K070226 * GE- CardlQ Fusion, K06 1370 * GE - Advanced Vessel Analysis LI, K060779 * Vital Imaging - Vitrea2 Ver. 3.9, K06 1624 (specifically…
GE Healthcare2006—
*K060779Advance Vessel Analysis II
Summary page 1
…V Configuration, K042293 * Shina Systems Ltd., CardioCT, K070226 * GE- CardlQ Fusion, K06 1370 * GE - Advanced Vessel Analysis LI, K060779 * Vital Imaging - Vitrea2 Ver. 3.9, K06 1624 (specifically the SUREPlaque tools) * Sie…
GE Healthcare2006—
*K061624Vitrea, Version 3.9
Summary page 1
…., CardioCT, K070226 * GE- CardlQ Fusion, K06 1370 * GE - Advanced Vessel Analysis LI, K060779 * Vital Imaging - Vitrea2 Ver. 3.9, K06 1624 (specifically the SUREPlaque tools) * Siemens - syngo Circulation, K063 762 Comprehensive Cardia…
Vital Images, Inc.20061
*K063762Syngo Circulation Software Package with Extended Functionality
Summary page 1
…is LI, K060779 * Vital Imaging - Vitrea2 Ver. 3.9, K06 1624 (specifically the SUREPlaque tools) * Siemens - syngo Circulation, K063 762 Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool Page III - 1 4. Device D…
Siemens AG Medical Solutions2007—

Also cleared against K042293: 5 other devices →

What descends from it? (19)

See all 19

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216
K240786AutoChamberHeartLung Corporation20241

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 18 years and passes through 5 companies; a new generation was cleared every 11 months on median.
  • 14 of the 63 ancestors have a recall of any class.
  • Of its descendants, K122429 (Object Research Systems (Ors), Inc., 2012) has gone furthest, with 16 descendants of its own.
  • 5 other devices also cite its predicate K042293.

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. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

The Plaque Analysis option is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.

Indications for use as stated in the FDA summary.

Also cleared against K042293

5 other devices cite the same predicate.

  • K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013
  • K1125303DI Including CscoreShina Systems, Ltd. · 2011
  • K101311EP Navigator R3Philips Medical Systems North America Co. · 2010
  • K062650EP Navigator SoftwarePhilips Medical Systems · 2006
  • K051351Precedence Spect/CT Imaging SystemAdac Laboratories · 20051 recall

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

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K092747 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092747

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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