510(k) · Cleared
ClearedAVVIGO™+ 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 Aug 21, 2026 as substantially equivalent to K230884 (Boston Scientific Corporation, 2023) after a 273-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Aug 21, 2026
- Review
- 273 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003122 (2001). 24 ancestors in all, the oldest K921750 (1992). No later device cites it as a predicate yet.
- Root · 12 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 8 generations between
- 3 generations backK201713 AVVIGO Guidance SystemBoston Scientific Corporation · 2020
- 2 generations backK212490 AVVIGO Guidance System IIBoston Scientific Corporation · 2021
- 1 generation backK230884 AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation · 2023 · Recalled
- This deviceK253692 AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026
Show all 12 generations
- Root · 12 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 11 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 10 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 9 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 8 generations backK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- 7 generations backK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
- 6 generations backK151613 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015
- 5 generations backK191008 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2019 · Recalled
- 4 generations backK201178 iLab Polaris Multi-Modality Guidance SystemBoston Scientific · 2020
- 3 generations backK201713 AVVIGO Guidance SystemBoston Scientific Corporation · 2020
- 2 generations backK212490 AVVIGO Guidance System IIBoston Scientific Corporation · 2021
- 1 generation backK230884 AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation · 2023 · Recalled
- This deviceK253692 AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −11 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −10 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −9 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −8 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| −7 | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
| −6 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | — |
| −5 | K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2019 | 1 |
| −4 | K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific | 2020 | — |
| −3 | K201713 | AVVIGO Guidance System | Boston Scientific Corporation | 2020 | — |
| −2 | K212490 | AVVIGO Guidance System II | Boston Scientific Corporation | 2021 | — |
| −1 | K230884 | AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation | 2023 | 22 |
| 0 (this device) | 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 |
| 2021 | 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 |
|---|---|---|---|
| * | K230884 | AVVIGO'+ Multi-Modality Guidance SystemSummary page 5…er, Ultrasonic, Diagnostic) Classification Class II, 21 CFR 870.1425 Predicate Device AVVIGO+™ Multi-Modality Guidance System K230884 cleared Sept 26, 2023 Device Description The AVVIGO™+ Multi-Modality Guidance System is used by physicians to obtain physiologic,… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 24 ancestors have a recall of any class.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 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…
Read the full statement (259 words)
The IVUS modality of the 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.
Refer to the Catheter Instructions for Use provided with all Boston Scientific Ultrasound Imaging Catheters
to determine compatibility with the System. All Ultrasound Imaging Catheters will be referred to as Imaging
Catheters throughout the remainder of this User Guide.
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 Instructions 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253692 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253692: AVVIGO™+ Multi-Modality Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253692
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026