510(k) · Cleared
ClearedAccuFFRangio Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArteryFlow Technology Co., Ltd. · QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Cleared on Mar 2, 2023 as substantially equivalent to K210093 (ArteryFlow Technology Co., Ltd., 2021) after a 27-day review. Its family tree reaches back 17 generations to 1993. 1 of the 102 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 2, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- QHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K926514 (1993). 101 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 102 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 13 generations between
- 3 generations backK180019 CAAS WorkstationPie Medical Imaging BV · 2018
- 2 generations backK182611 Qangio XA 3DMedis Medical Imaging Systems BV · 2019
- 1 generation backK210093 AccuFFRangioArteryFlow Technology Co., Ltd. · 2021
- This deviceK230303 AccuFFRangio PlusArteryFlow Technology Co., Ltd. · 2023
Show all 17 generations
- Root · 17 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 16 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 15 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 14 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 13 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 12 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 11 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 10 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 9 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 8 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 7 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 6 generations backK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- 5 generations backK133993 Caas WorkstationPie Medical Imaging · 2014
- 4 generations backK151780 CAAS WorkstationPie Medical Imaging BV · 2016
- 3 generations backK180019 CAAS WorkstationPie Medical Imaging BV · 2018
- 2 generations backK182611 Qangio XA 3DMedis Medical Imaging Systems BV · 2019
- 1 generation backK210093 AccuFFRangioArteryFlow Technology Co., Ltd. · 2021
- This deviceK230303 AccuFFRangio PlusArteryFlow Technology Co., Ltd. · 2023
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…15 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −16 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −15 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −14 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −13 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −12 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −11 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −10 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −9 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −8 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −7 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −6 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| −5 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
| −4 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | — |
| −3 | K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018 | — |
| −2 | K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019 | — |
| −1 | K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021 | — |
| 0 (this device) | K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 1 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 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 QHA device
- #1 K251355 X1-FFRscore 14.4 · 15 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 |
|---|---|---|---|
| * | K210093 | AccuFFRangioSummary page 4…ogical Image Processing Software Regulatory Class: Class II Regulation Number: 892.1600 Classification Product Code: QHA Subsequent Product Code: LLZ 510(k) number: K210093 1 Special 510(k) Summary 4. Device Description AccuFFRan… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 15 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 22 of the 101 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K210093.
How does its category compare?
All QHA devicesQHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QHA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHA
Too few QHA 510(k)s in any year since 2007 to give a median.
Recalls per year · QHA
No recall names QHA since 2007.
Adverse event reports per year · QHA
No MAUDE report names QHA since 2007.
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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AccuFFRangio Plus is indicated for use in clinical settings where validated and repreproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease.
When the quantified results provided by AccuFFRangio Plus are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230303: AccuFFRangio Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230303
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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