510(k) Report

510(k) · Cleared

Cleared

Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter

K111043510(k) TraditionalCleared Aug 4, 2011111-day reviewClass II21 CFR 870.1200

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

Boston Scientific Corp · OBJ Catheter, Ultrasound, Intravascular

Cleared on Aug 4, 2011 as substantially equivalent to K063312 (Boston Scientific Corp, 2006) after a 111-day review. Its family tree reaches back 2 generations to 2005. 9 later devices descend from it.

Decided
Aug 4, 2011
Review
111 days
Class
Class II
Product code
OBJ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K050577 (2005). 9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2016: 2 descendants cleared2025: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK050577 · Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 · Boston Scientific Corp · 2005 · recalledK063312 · Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and 38942 · Boston Scientific Corp · 2006 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K063312 · Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and 38942 · Boston Scientific Corp · 2006 · recalledK050577 · Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 · Boston Scientific Corp · 2005 · recalled0+5
  1. Root · 2 generations backK050577 Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp · 2005 · Recalled
  2. 1 generation backK063312 Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging…Boston Scientific Corp · 2006 · Recalled
  3. This deviceK111043 Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging…Boston Scientific Corp · 2011
  4. Descendant · cites it directly · 8 of its ownK123621 Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · Recalled
  5. Descendant · 2 generations on · 5 of its ownK153617 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution)…Boston Scientific Corporation · 2016
  6. Descendant · 3 generations on · 3 of its ownK173820 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2018
  7. Descendant · 2 generations on · 3 of its ownK173284 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2017
  8. Descendant · 3 generations on · 2 of its ownK213593 OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation · 2022 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2013: 12016: 22017: 12018: 12022: 12023: 12025: 12026: 1
2013high 2 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 9 · See all
  • K123621Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · cites it directly8descendants
  • K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…Boston Scientific Corporation · 2016 · 2 generations on5descendants
  • K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…Boston Scientific Corporation · 2018 · 3 generations on3descendants
  • K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz…Boston Scientific Corporation · 2017 · 2 generations on3descendants
  • K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation · 2022 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K050577Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp20052
−1K063312Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model…Boston Scientific Corp20062
0 (this device)K111043Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterBoston Scientific Corp2011—
+1K123621Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp20131
+2K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6…Boston Scientific Corporation2016—
+3K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD…Boston Scientific Corporation2018—
+2K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60…Boston Scientific Corporation2017—
+3K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation20221

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201620
201710
201810
202210
202310
202510
202610
FIG. 1 — Lineage of K111043, 2005–2026Source: 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 OBJ? 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 OBJ device

  1. #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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
*K063312Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and…
Summary page 1
…- iCross TM Corona? Imaging Catheter AtlantisTM SR Pro Coronary Imaging Catheter K0633 12, cleared on November 30, 2006 Device Description: The Catheters are sterile, single use, short rail (SR) 40MHz imaging catheters…
Boston Scientific Corp20062

Also cleared against K063312: 1 other device →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K123621Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp20138

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 6 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K123621 (Boston Scientific Corp, 2013) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K063312.

How does its category compare?

All OBJ devices

OBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OBJ

7in 2025

2007: 32008: 62009: 32010: 12011: 42012: 32013: 42014: 32015: 42016: 42017: 62018: 22019: 12020: 42021: 32022: 32023: 32024: 32025: 72026 (partial year): 4
2007high 7 (2025) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBJ

35in 2025

2007: 74 days median2008: 100 days median2009: 108 days median2011: 109 days median2012: 136 days median2013: 96 days median2014: 30 days median2015: 131 days median2016: 94 days median2017: 45 days median2020: 135 days median2021: 29 days median2022: 63 days median2023: 63 days median2024: 131 days median2025: 35 days median2026 (partial year): 81 days median
2007high 136 (2012) · low 29 (2021)2026

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

Recalls per year · OBJ

2in 2020

2015: 22017: 22018: 22020: 22026 (partial year): 1, 1 Class I
2007high 2 (2015) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OBJ

791in 2025

2008: 62009: 222010: 392011: 472012: 532013: 3282014: 6092015: 4012016: 5152017: 5242018: 5422019: 2372020: 2882021: 3532022: 4732023: 6972024: 1,1542025: 791
2007high 1,154 (2024) · low 0 (2007)2025

MAUDE reports naming product code OBJ, 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
200737400
2008610006
20093108022
20101—039
20114109047
20123136053
20134960328
20143300609
201541312401
20164940515
20176452524
20182—2542
20191—0237
202041352288
20213290353
20223630473
20233630697
2024313101,154
20257350791
20264811 (1)—

What is it indicated for?

The iCrossTM and AtlantisrM SR Pro 2 Coronary Imaging Catheters are intended for

ultrasound examination of coronary intravascular pathology only.

Intravascular ultrasound imaging is indicated in patients who are candidates for

translumninal coronary interventional procedures.

Indications for use as stated in the FDA summary.

Also cleared against K063312

1 other device cites the same predicate.

  • K073623Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp · 2008

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Recent decisions in OBJ

The OBJ category page

  • K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
  • K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited · 2026
  • K252945Novasight Hybrid SystemConavi Medical, Inc. · 2026
  • K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160)…Boston Scientific · 2026
  • K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device · 2025

https://510kreport.com/device/K111043 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111043: Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111043

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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