510(k) Report

510(k) · Cleared

Cleared

Ultraguide CTG 2000SA

K022354510(k) SpecialCleared Aug 13, 200225-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

Ultraguide, Ltd. · JAK System, X-Ray, Tomography, Computed

Cleared on Aug 13, 2002 as substantially equivalent to K002258 (Ultraguide, Ltd., 2000) after a 25-day review. Its family tree reaches back 1 generation to 2000. 7 of the 356 devices in its family, counting itself, have a Class I recall. 354 later devices descend from it.

Decided
Aug 13, 2002
Review
25 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002258 (2000). 354 later devices descend from it, 3 citing it directly. 7 of the 356 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2006: 3 descendants cleared2011: 6 descendants cleared2004: 1 descendant cleared2009: 10 descendants cleared2008: 5 descendants cleared2005: 3 descendants cleared2014: 15 descendants cleared2012: 10 descendants cleared2015: 19 descendants cleared2010: 4 descendants cleared2026: 25 descendants cleared2013: 4 descendants cleared2016: 18 descendants cleared2018: 22 descendants cleared2017: 32 descendants cleared2021: 26 descendants cleared2007: 1 descendant cleared2020: 30 descendants cleared2019: 20 descendants cleared, 1 with a Class I recall12023: 21 descendants cleared, 1 with a Class I recall12025: 33 descendants cleared, 3 with a Class I recall32022: 23 descendants cleared2024: 23 descendants cleared, 2 with a Class I recall2K002258 · Ultraguide CT-Guide 1010 · Ultraguide, Ltd. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 18 descendants4 generations forward: 28 descendants5 generations forward: 42 descendants6 generations forward: 41 descendants7 generations forward: 43 descendants8 generations forward: 44 descendants, 2 with a Class I recall29 generations forward: 43 descendants10 generations forward: 31 descendants11 generations forward: 23 descendants, 1 with a Class I recall112 generations forward: 14 descendants, 4 with a Class I recall413 generations forward: 7 descendants14 generations forward: 3 descendants15 generations forward: 2 descendants K002258 · Ultraguide CT-Guide 1010 · Ultraguide, Ltd. · 20000+5+10+15
  1. Root · 1 generation backK002258 Ultraguide CT-Guide 1010Ultraguide, Ltd. · 2000
  2. This deviceK022354 Ultraguide CTG 2000SAUltraguide, Ltd. · 2002
  3. Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
  5. Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
  6. Descendant · 4 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
  7. Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled

Showing 5 of 354 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 32007: 12008: 52009: 102010: 42011: 62012: 102013: 42014: 152015: 192016: 182017: 322018: 222019: 202020: 302021: 262022: 232023: 212024: 232025: 332026: 25
2004high 33 (2025) · low 1 (2004)2026

Class I recalls in this family

  • K242670 Lumify Diagnostic Ultrasound System8 generations on · 2025
  • K242519 Lumify Diagnostic Ultrasound System8 generations on · 2025
  • K190106 Intra-Operative Positioning System; Simple Curve…11 generations on · 2019
  • K242133 Intra-Operative Positioning System (IOPS®)…12 generations on · 2024

Most influential descendants

Showing 5 of 354 · See all
  • K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
  • K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
  • K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
  • K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 4 generations on100descendants
  • K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002258Ultraguide CT-Guide 1010Ultraguide, Ltd.2000—
0 (this device)K022354Ultraguide CTG 2000SAUltraguide, Ltd.2002—
+1K053610AbarisTraxtal Technologies, Inc.20063
+2K121498PercunavPhilips Health Care2012—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201336
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System…Philips Ultrasound, Inc.201633
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20143

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200630
200710
200850
2009100
201040
201160
2012100
201340
2014150
2015190
2016180
2017320
2018220
2019201
2020300
2021260
2022230
2023211
2024232
2025333
2026250
FIG. 1 — Lineage of K022354, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

7 devices in this family have a Class I recall. 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? (1)

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
*K002258Ultraguide CT-Guide 1010Ultraguide, Ltd.2000—

Also cleared against K002258: 5 other devices →

What descends from it? (354)

See all 354

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

NumberDeviceApplicantDecidedDescendants
K053610AbarisTraxtal Technologies, Inc.2006278
K042438Superdimension/BronchusSuperdimension, Ltd.200473
K090754LipocontrolOsyris Medical20110

Has anything in its family been recalled? (7 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
  • K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 11 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
  • K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 12 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 12 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 12 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K053610 (Traxtal Technologies, Inc., 2006) has gone furthest, with 278 descendants of its own.
  • 5 other devices also cite its predicate K002258.

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?

The CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.

The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.

Indications for use as stated in the FDA summary.

Also cleared against K002258

5 other devices cite the same predicate.

  • K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal TrackerCivco · 200917 recalls
  • K080624Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
  • K060903IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
  • K053610AbarisTraxtal Technologies, Inc. · 20063 recalls
  • K013150MR-Guide 2000Ultraguide, Ltd. · 2001

More from Ultraguide, Ltd.

6 FDA decisions under this applicant name. See the company

  • K023227USG 2000SAUltraguide, Ltd. · 2002
  • K013150MR-Guide 2000Ultraguide, Ltd. · 2001
  • K011418Ultraguide MR-Guide 3000Ultraguide, Ltd. · 2001
  • K002258Ultraguide CT-Guide 1010Ultraguide, Ltd. · 2000
  • K974432Ultraguide 1000Ultraguide, Ltd. · 1998

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/K022354 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022354: Ultraguide CTG 2000SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022354

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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