510(k) · Cleared
ClearedC7 XR Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightlab Imaging, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Aug 10, 2011 as substantially equivalent to K093857 (Lightlab Imaging, Inc., 2010) and 2 other predicates after a 103-day review. Its family tree reaches back 7 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 10, 2011
- Review
- 103 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K003122 (2001). 25 ancestors in all, the oldest K883651 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 6 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 5 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 4 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 3 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 2 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 1 generation backK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- This deviceK111201 C7 XR Imaging SystemLightlab Imaging, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK150237 ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK192267 ILUMIEN System with AptiVue Software version D.3Abbott Medical · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −6 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −5 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −4 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −3 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −2 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −1 | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver | Radi Medical Systems AB | 2008 | — |
| 0 (this device) | K111201 | C7 XR Imaging System | Lightlab Imaging, Inc. | 2011 | — |
| +1 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | Lightlab Imaging, Inc. | 2015 | — |
| +2 | K192267 | ILUMIEN System with AptiVue Software version D.3 | Abbott Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 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 NQQ? 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 NQQ device
- #1 K251730 LIA Console (542-7)score 16.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K093857 | C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable AccessoriesSummary page 2…maging System PtY / 0'-i 0 Proposed Device Description: The C7 XRTM Imaging System K093857 (C7 XR) and DragonflyTM Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are c… | 2010 |
| * | K092105 | Radianalyzer XpressSummary page 3…C7 XJ{TM Imaging System with C7 DragonflyTM Imaging Catheter SE Date: 04/30/2010 Manufacturer: LightLab Imaging, Inc. * 510(k) No.: K092105 Trade Name: RadiAnalyzert Xpress SE Date: 10/09/2009 Manufacturer: Radi Medical Systems AB, Inc… | 2009 |
| * | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverSummary page 3…: K092105 Trade Name: RadiAnalyzert Xpress SE Date: 10/09/2009 Manufacturer: Radi Medical Systems AB, Inc. * 510(k) No.: K080813 Trade Name: Pressure Wireg SE Date: 7/01/2008 Manufacturer: Radi Medical Systems AB, Inc. Sub… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | 2015 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K150237 (Lightlab Imaging, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093857.
How does its category compare?
All NQQ devicesNQQ System, Imaging, Optical Coherence Tomography (Oct): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NQQ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQQ
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQQ
2in 2025
MAUDE reports naming product code NQQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 82 | 1 | 0 |
| 2011 | 2 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 5 | 91 | 0 | 3 |
| 2016 | 5 | 91 | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 84 | 0 | 6 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 3 | 86 | 0 | 6 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 8 | 146 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The C7 XRTM Imaging System with C7 DragonflylV Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 DragonflyTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 DragonfIyTM Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass…
Read the full statement (134 words)
The C7 XRTM Imaging System with C7 DragonflylV Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 DragonflyTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 DragonfIyTM Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The C7 XRTM Imaging System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal sortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (PER). The physician may use the PER parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111201: C7 XR Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111201
Report an extraction error
Are you the manufacturer?
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