510(k) · Cleared
Recalled · 2006Ilab Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · OBJ Catheter, Ultrasound, Intravascular
Cleared on Jul 14, 2005 as substantially equivalent to K980851 (Boston Scientific Corp, 1998) after a 21-day review. Its family tree reaches back 2 generations to 1992. 1 of the 41 devices in its family, counting itself, has a Class I recall. 36 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 14, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921750 (1992). 4 ancestors in all. 36 later devices descend from it, 5 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 1 generation backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- This deviceK051679 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005
- Descendant · cites it directly · 28 of its ownK072517 Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · Recalled
- Descendant · 2 generations on · 27 of its ownK123535 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- Descendant · 3 generations on · 26 of its ownK130243 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- Descendant · 4 generations on · 11 of its ownK170948 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2017
- Descendant · 4 generations on · 10 of its ownK151613 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193183 ACIST HDi System, ACIST Kodama Intravascular…4 generations on · 2020
Most influential descendants
Showing 5 of 36 · See all- K072517Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · cites it directly28descendants
- K123535Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013 · 2 generations on27descendants
- K130243Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013 · 3 generations on26descendants
- K170948AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2017 · 4 generations on11descendants
- K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −1 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| 0 (this device) | K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2005 | — |
| +1 | K072517 | Ilab Ultrasound Imaging System, Version 1.3 | Boston Scientific Corp | 2007 | 1 |
| +2 | K123535 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| +3 | K130243 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| +4 | K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2017 | — |
| +4 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 1 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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.
1 device in this family has 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980851 | Galaxy Intravascular Ultrasound System, Model I5028Summary page 1…I Produt 51 k ClearancePate Galax Intravascular Ultrasound System K980851 ArI22, 1998 Description of the Device The iLabTM Ultrasound Imaging System is a combination of proprietary hardware and soft… | 1998 |
What descends from it? (36)
See all 365 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072517 | Ilab Ultrasound Imaging System, Version 1.3 | 2007 | 28 |
| K112997 | HD-Ivus Ultrasound Imaging System | 2011 | 4 |
| K122878 | HD-Ivus Ultrasound Imaging System | 2013 | 3 |
| K093993 | Lipiscan Ivus Imaging System Model Nirs-MC7-70 | 2010 | 0 |
| K063493 | I Review Software (Accessory to) Ilab Ultrasound Imaging System) VERSION1.0 | 2006 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2006 | Not classified | Z-0395-2007 | Other | The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions. |
| Mar 6, 2006 | Not classified | Z-0789-06 | Other | Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only) |
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.
- K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072517 (Boston Scientific Corp, 2007) has gone furthest, with 28 descendants of its own.
- 6 other devices also cite its predicate K980851.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The iLabTM Ultrasound Imaging Systemr is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051679 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051679: Ilab Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051679
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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