510(k) · Cleared
ClearedCanvas N-Vas-D 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vassol, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 5, 2002 as substantially equivalent to K923077 (GE Medical Systems, 1993) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Feb 5, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923077 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923077 Advantage Windows 3D Option and Dentascan OptionGE Medical Systems · 1993
- This deviceK014011 Canvas N-Vas-D 2.0Vassol, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923077 | Advantage Windows 3D Option and Dentascan Option | GE Medical Systems | 1993 | — |
| 0 (this device) | K014011 | Canvas N-Vas-D 2.0 | Vassol, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 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? (2)
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 |
|---|---|---|---|
| * | K923077 | Advantage Windows 3D Option and Dentascan OptionSummary page 1…92.1000 Performance Standards: No performance standards have been developed for this device. Devices to which we claim Substantial Equivalence: GE Advantage Windows (K923077A) & GE “Magnetic Resonance Diagnostic Accessory” (K924605). The intended use of the device to which we claim substantial equival… | 1993 |
| * | K924605 | Magnetic Resonance Diagnostic AccessorySummary page 1…have been developed for this device. Devices to which we claim Substantial Equivalence: GE Advantage Windows (K923077A) & GE “Magnetic Resonance Diagnostic Accessory” (K924605). The intended use of the device to which we claim substantial equivalence: The General Electric Flow Analysis Option (1(924605… | 1993 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K923077.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
N-VAS-D is designed and intended for use as a supporting tool to non-invasive
assessment of the vascular system. Intended purposes are:
Supporting clinical diagnoses about the flow velocity and volume flow through
the vascular system.
Supporting subsequent clinical decision making purposes.
Supporting clinical post-operation and follow-up evaluation about the flow
velocity and volume flow throughout the vascular system.
Supporting the use in the treatment planning using computer modeling of the
vascular system.
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/K014011 · printed Nov 5, 2026
Cite this page
510(k) Report. “K014011: Canvas N-Vas-D 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K014011
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026