510(k) · Cleared
ClearediLab Polaris Multi-Modality Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · DQK Computer, Diagnostic, Programmable
Cleared on May 29, 2020 as substantially equivalent to K191008 (Boston Scientific Corporation, 2019) after a 28-day review. Its family tree reaches back 8 generations to 2001. 6 later devices descend from it.
- Decided
- May 29, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003122 (2001). 19 ancestors in all, the oldest K921750 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 7 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 6 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 5 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 4 generations backK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- 3 generations backK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
- 2 generations backK151613 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015
- 1 generation backK191008 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2019 · Recalled
- This deviceK201178 iLab Polaris Multi-Modality Guidance SystemBoston Scientific · 2020
- Descendant · cites it directly · 4 of its ownK210889 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2021
- Descendant · cites it directly · 4 of its ownK201713 AVVIGO Guidance SystemBoston Scientific Corporation · 2020
- Descendant · 2 generations on · 3 of its ownK212490 AVVIGO Guidance System IIBoston Scientific Corporation · 2021
- Descendant · 3 generations on · 1 of its ownK230884 AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation · 2023 · Recalled
- Descendant · 4 generations on · 0 of its ownK253692 AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2021 · cites it directly4descendants
- K201713AVVIGO Guidance SystemBoston Scientific Corporation · 2020 · cites it directly4descendants
- K212490AVVIGO Guidance System IIBoston Scientific Corporation · 2021 · 2 generations on3descendants
- K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation · 2023 · 3 generations on1descendant
- K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −7 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −6 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −5 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −4 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| −3 | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
| −2 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | — |
| −1 | K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2019 | 1 |
| 0 (this device) | K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific | 2020 | — |
| +1 | K210889 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2021 | — |
| +1 | K201713 | AVVIGO Guidance System | Boston Scientific Corporation | 2020 | — |
| +2 | K212490 | AVVIGO Guidance System II | Boston Scientific Corporation | 2021 | — |
| +3 | K230884 | AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation | 2023 | 22 |
| +4 | K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 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.
Planning a device in DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 |
|---|---|---|---|
| * | K191008 | iLab Polaris Multi-Modality Guidance SystemSummary page 4…DQK, DSK, IYO, ITX Classification Class II, 21 CFR 870.1425 Predicate Device iLab™ Polaris Multi -Modality Guidance System K191008, July 2, 2019 Device Description The iLab™ Polaris Multi-Modality Guidance System is a non-patient contacting, diagnostic device… | 2019 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K210889 (Boston Scientific Corporation, 2021) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K191008.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System 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. FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on…
Read the full statement (224 words)
The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System 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.
FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.
FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.
The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.
Indications for Auto Pullback Use (IVUS Only)
Automatic Pullback is indicated when the following occurs:
• The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.
• The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.
• Two-dimensional, longitudinal reconstruction of the anatomy is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201178 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201178: iLab Polaris Multi-Modality Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201178
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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