510(k) Report

510(k) · Cleared

Cleared

Fluoroscan Profile, Model Tca 4 Plus; Fluoroscan Profile IQ, Model Tca 4R Plus

K002198510(k) TraditionalCleared Oct 17, 200089-day reviewClass II21 CFR 892.1650

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

Fluoro Scan Imaging Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Oct 17, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Oct 17, 2000
Review
89 days
Class
Class II
Product code
OWB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared200020052010201520202025
  1. This deviceK002198 Fluoroscan Profile, Model Tca 4 Plus; Fluoroscan Profile IQ, Model…Fluoro Scan Imaging Systems, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK070123 TCA 5R / 5SDornier Medtech America, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K070123TCA 5R / 5SDornier Medtech America, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002198Fluoroscan Profile, Model Tca 4 Plus; Fluoroscan Profile IQ, Model Tca 4R PlusFluoro Scan Imaging Systems, Inc.2000—
+1K070123TCA 5R / 5SDornier Medtech America, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K002198, 2000–2007Source: 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 OWB? 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 OWB device

  1. #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 18 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K070123TCA 5R / 5SDornier Medtech America, Inc.20070

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?

  • Of its descendants, K070123 (Dornier Medtech America, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All OWB devices

OWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OWB

22in 2025

2007: 32008: 42009: 92010: 72011: 62012: 62013: 112014: 152015: 112016: 162017: 202018: 232019: 92020: 162021: 242022: 212023: 122024: 132025: 222026 (partial year): 15
2007high 24 (2021) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWB

148in 2025

2007: 52 days median2008: 135 days median2009: 99 days median2010: 66 days median2011: 79 days median2012: 37 days median2013: 119 days median2014: 158 days median2015: 66 days median2016: 103 days median2017: 76 days median2018: 54 days median2019: 174 days median2020: 53 days median2021: 60 days median2022: 90 days median2023: 152 days median2024: 126 days median2025: 148 days median2026 (partial year): 221 days median
2007high 221 (2026) · low 37 (2012)2026

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

Recalls per year · OWB

42so far in 2026, the most since 2007

2008: 12013: 102014: 92015: 352016: 132017: 132018: 62019: 72020: 82021: 312022: 242023: 222024: 112025: 302026 (partial year): 42
2007high 42 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OWB

14,008in 2025

2007: 12011: 12012: 12013: 272014: 1032015: 2,1342016: 4,0742017: 1,6042018: 1,4492019: 1,5582020: 1,5812021: 1,9812022: 2,9322023: 7,6042024: 7,9422025: 14,008
2007high 14,008 (2025) · low 0 (2008)2025

MAUDE reports naming product code OWB, 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
200735201
2008413510
200999900
201076600
201167901
201263701
2013111191027
2014151589103
20151166352,134
201616103134,074
20172076131,604
2018235461,449
2019917471,558
2020165381,581
20212460311,981
20222190242,932
202312152227,604
202413126117,942
2025221483014,008
20261522142—

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https://510kreport.com/device/K002198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002198: Fluoroscan Profile, Model Tca 4 Plus; Fluoroscan Profile IQ, Model Tca 4R Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002198

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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