510(k) · Cleared
Cleared2D Quantitative Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jul 29, 2016 as substantially equivalent to K141979 (Philips Medical Systems Netherland BV, 2014) after a 24-day review. Its family tree reaches back 12 generations to 1980. 1 of the 54 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 29, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K801623 (1980). 53 ancestors in all. No later device cites it as a predicate yet. 1 of the 54 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations between
- 3 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 2 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 1 generation backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- This deviceK161839 2D Quantitative AnalysisPhilips Medical Systems Nederland B.V. · 2016
Show all 12 generations
- Root · 12 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 11 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 10 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 9 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 8 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 7 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 6 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 5 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 4 generations backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- 3 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 2 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 1 generation backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- This deviceK161839 2D Quantitative AnalysisPhilips Medical Systems Nederland B.V. · 2016
Class I recalls in this family
- K033737 Allura Xper FD204 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −11 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −10 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −9 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −8 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −7 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −6 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −5 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −4 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| −3 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| −2 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| −1 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| 0 (this device) | K161839 | 2D Quantitative Analysis | Philips Medical Systems Nederland B.V. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 1 |
| 2004 | 3 | 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K141979 | Allura Xper FD Series / Allura Xper or Table SeriesSummary page 4…series Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K141979 (Aug 19, 2014) Classification Name: Image-intensified fluoroscopic x-ray system… | 2014 |
| † | K100292 | Caas Qva 3D, Caas Qca 3D | 2010 |
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.
- K033737Allura Xper FD20Philips Medical Systems North America, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 113 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 19 of the 53 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K141979.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
2D Quantitative Analysis is a post processing software medical device intended to assist physicians through providing quantitative information as additional input for their comprehensive diagnosis decision making process and planning during cardiovascular procedures and for post procedural evaluation. 2D Quantitative Analysis consists of six applications: The 2D Quantitative Coronary Analysis application is intended to be used for quantification of…
Read the full statement (171 words)
2D Quantitative Analysis is a post processing software medical device intended to assist physicians through providing quantitative information as additional input for their comprehensive diagnosis decision making process and planning during cardiovascular procedures and for post procedural evaluation. 2D Quantitative Analysis consists of six applications:
The 2D Quantitative Coronary Analysis application is intended to be used for quantification of coronary artery dimensions (approximately 1 to 6 mm) from 2D angiographic images.
The 2D Quantitative Vascular Analysis application is intended to be used for quantification of aortic and peripheral artery dimensions (approximately 5 to 50 mm) from 2D angiographic images.
The 2D Left Ventricle Analysis and the Biplane 2D Left Ventricle Analysis applications are intended to be used for quantification of left ventricular volumes and local wall motion from monoplane and from biplane angiographic series, respectively.
The 2D Right Ventricle Analysis and the Biplane 2D Right Ventricle Analysis applications are intended to be used for quantification of right ventricular volumes and local wall motion from monoplane and from biplane angiographic series, respectively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161839: 2D Quantitative Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161839
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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