510(k) Report

510(k) · Cleared

Cleared

N-Vivo Calcium Score on IA Chassis Release, Model Release X.XX

K040782510(k) TraditionalCleared Jul 13, 2004109-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

Image Analysis, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jul 13, 2004 as substantially equivalent to K972903 (Imatron, Inc., 1997) and 2 other predicates after a 109-day review. Its family tree reaches back 4 generations to 1995.

Decided
Jul 13, 2004
Review
109 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K945188 (1995). 11 ancestors in all, the oldest K864854 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 3 other ancestors1989: 2 other ancestors1995: 1 other ancestor1987: 1 other ancestorK945188 · Cemax Vipstation and/or Software · Cemax, Inc. · 1995K961023 · Aidp (Accuimage Image Display Processor) · Accuimage, Inc. · 1996K982535 · Insight Diagnostic Imaging Workstation · Neo Imagery Technologies, Inc. · 1998K990241 · Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip · Accuimage Diagnostics Corp. · 199919851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 2 other ancestors K990241 · Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip · Accuimage Diagnostics Corp. · 1999K982535 · Insight Diagnostic Imaging Workstation · Neo Imagery Technologies, Inc. · 1998K961023 · Aidp (Accuimage Image Display Processor) · Accuimage, Inc. · 1996K945188 · Cemax Vipstation and/or Software · Cemax, Inc. · 19950
  1. Root · 4 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
  2. 3 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
  3. 2 generations backK982535 Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998
  4. 1 generation backK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
  5. This deviceK040782 N-Vivo Calcium Score on IA Chassis Release, Model Release X.XXImage Analysis, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945188Cemax Vipstation and/or SoftwareCemax, Inc.1995—
−3K961023Aidp (Accuimage Image Display Processor)Accuimage, Inc.1996—
−2K982535Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc.1998—
−1K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze…Accuimage Diagnostics Corp.1999—
0 (this device)K040782N-Vivo Calcium Score on IA Chassis Release, Model Release X.XXImage Analysis, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198920
199510
199730
FIG. 1 — Lineage of K040782, 1995–2004Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K972903Imatron Ultra Access Workstation with Cardiac Software Extensions
Summary page 1
…N-Vivo TM Calcium Score operating on the IA Chassis is substantially equivalent to currently marketed devices including: K972903 UltraAccess Workstation with Cardiac Score, K990241 AccuView with AccuScore, K891…
Imatron, Inc.1997—
*K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…
Summary page 1
…is substantially equivalent to currently marketed devices including: K972903 UltraAccess Workstation with Cardiac Score, K990241 AccuView with AccuScore, K891931 QCT-Lung nodule analysis. Device Description: A software package ope…
Accuimage Diagnostics Corp.1999—
*K891931QCT-Lung Nodule (TM) Analysis Package
Summary page 1
…urrently marketed devices including: K972903 UltraAccess Workstation with Cardiac Score, K990241 AccuView with AccuScore, K891931 QCT-Lung nodule analysis. Device Description: A software package operating on a PC which facilitates non-invasive measurement…
Image Analysis, Inc.1989—

Also cleared against K972903: 4 other devices →

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?

  • The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
  • None of the 11 ancestors has a recall.
  • 4 other devices also cite its predicate K972903.

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—

What is it indicated for?

N-VivoTM Calcium Score is a calibrated software program for non-invasive identification and quantification of calcified plaques in the coronary arteries and aorta using CT images. The software runs on a standard PC with basic image processing, database and reporting functions.

N-VivoTM may be used to monitor progression/regression of calcium which may be useful in the prognosis of cardiovascular disease.

Indications for use as stated in the FDA summary.

Also cleared against K972903

4 other devices cite the same predicate.

  • K060035MdxnetCybermdx, Inc. · 2006
  • K012086Aquariusnet ServerTerarecon,Inc. · 2001
  • K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt…Accuimage Diagnostics Corp. · 1999
  • K990426Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999

More from Image Analysis, Inc.

9 FDA decisions under this applicant name. See the company

  • K031991Dxaview Spine and Hip, Model QCT-3D PlusImage Analysis, Inc. · 2003
  • K992246QCT Bone Mineral Analysis SoftwareImage Analysis, Inc. · 1999
  • K952060QCT-Bone Mineral Analysis Software or Oct-BMD Option or Oct-5000Image Analysis, Inc. · 1995
  • K941127QCT-Bone Mineral Analysis SoftwareImage Analysis, Inc. · 1995
  • K941126QCT-Bone Mineral Analysis PhantomImage Analysis, Inc. · 1995

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/K040782 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040782: N-Vivo Calcium Score on IA Chassis Release, Model Release X.XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040782

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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