510(k) Report

510(k) · Cleared

Cleared

Colon View, Model CSCV-001A

K090220510(k) TraditionalCleared Feb 11, 200913-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

Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed

Cleared on Feb 11, 2009 as substantially equivalent to K041270 (General Electric Medical Systems, 2004) and 3 other predicates after a 13-day review. Its family tree reaches back 4 generations to 1995.

Decided
Feb 11, 2009
Review
13 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K954355 (1995). 14 ancestors in all, the oldest K923524 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors1997: 2 other ancestors1994: 1 other ancestor2000: 2 other ancestorsK954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 1995K012313 · CT Colonography/NAVIGATOR2 · Ge Medical Systems, Inc. · 2001 · recalledK023943 · CT Colonography · Ge Medical Systems, Inc. · 2003K041270 · CT Colonography II · General Electric Medical Systems · 200419901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors K041270 · CT Colonography II · General Electric Medical Systems · 2004K023943 · CT Colonography · Ge Medical Systems, Inc. · 2003K012313 · CT Colonography/NAVIGATOR2 · Ge Medical Systems, Inc. · 2001 · recalledK954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 19950
  1. Root · 4 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
  2. 3 generations backK012313 CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001 · Recalled
  3. 2 generations backK023943 CT ColonographyGe Medical Systems, Inc. · 2003
  4. 1 generation backK041270 CT Colonography IIGeneral Electric Medical Systems · 2004
  5. This deviceK090220 Colon View, Model CSCV-001AToshibamedical Systems Corporation · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K954355Advantage Windows 3D with Navigator OptionGeneral Electric Co.1995—
−3K012313CT Colonography/NAVIGATOR2Ge Medical Systems, Inc.20011
−2K023943CT ColonographyGe Medical Systems, Inc.2003—
−1K041270CT Colonography IIGeneral Electric Medical Systems2004—
0 (this device)K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199720
200020
200120
200210
200310
200410
FIG. 1 — Lineage of K090220, 1995–2009Source: 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? (4)

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
*K041270CT Colonography II
Summary page 1
…21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Predicate Device(s): GE CT Colonography 11 [k041270] GE Ct Colonography [k023943] Siemens syngo Colonography…
General Electric Medical Systems2004—
*K023943CT Colonography
Summary page 1
…Federal Diagnostic X-ray Equipment Standard Predicate Device(s): GE CT Colonography 11 [k041270] GE Ct Colonography [k023943] Siemens syngo Colonography [k042605] Siemens syngo Colon…
Ge Medical Systems, Inc.2003—
*K042605Colongraphy Software Package with Extended Functionality
Summary page 1
…GE CT Colonography 11 [k041270] GE Ct Colonography [k023943] Siemens syngo Colonography [k042605] Siemens syngo Colonography [k03 0982] Reason For Submission New software pack…
Siemens AG Medical Solutions2004—
*K030982Syngo Colonography Software Package
Summary page 1
…GE Ct Colonography [k023943] Siemens syngo Colonography [k042605] Siemens syngo Colonography [k03 0982] Reason For Submission New software package Description of this Device: Colon View is a post processing softwa…
Siemens Medical Solutions USA, Inc.2003—

Also cleared against K041270: 1 other device →

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 14 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
  • 3 of the 14 ancestors have a recall of any class.
  • 1 other device also cites its predicate K041270.

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?

This application software is an image analysis package that allows for the visualization of

the colon using volume datasets that provide 2D, 3D and MPR images. When employed

by a qualified physician, this package can be used to observe polyps, masses and other

lesions of the colon. Upon observation of the potential lesion the physician can mark and

categorize the observed lesion.

This package also allows for the generation of reports that can be exported to DICOM

based PACS systems for the continued tracking of changes in the colon.

Indications for use as stated in the FDA summary.

Also cleared against K041270

1 other device cites the same predicate.

  • K061372Centricity AW Suite OptionGe Healthcare Information Technologies · 20062 recalls

More from Toshibamedical Systems Corporation

80 FDA decisions under this applicant name. See the company

  • K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation · 2018
  • K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 20181 recall
  • K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
  • K173382Vantage Galan 3T, V4.6Toshibamedical Systems Corporation · 2018
  • K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018

Recent decisions in JAK

The JAK category page

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https://510kreport.com/device/K090220 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090220: Colon View, Model CSCV-001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090220

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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