510(k) · Cleared
Recalled · Class II · 2013Edge/Vista System Enhancement Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 10, 1997 as substantially equivalent to K931544 (Philips Medical Systems (Cleveland), Inc., 1993) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1993. 15 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 10, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931544 (1993). 3 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
- 1 generation backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
- This deviceK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997
- Descendant · cites it directly · 11 of its ownK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- Descendant · 2 generations on · 5 of its ownK013858 Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · Recalled
- Descendant · 2 generations on · 4 of its ownK024042 Panorama EnhancementsPhilips Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 4 of its ownK983342 MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- Descendant · 3 generations on · 3 of its ownK071154 Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K974844Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998 · cites it directly11descendants
- K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · 2 generations on5descendants
- K024042Panorama EnhancementsPhilips Medical Systems, Inc. · 2003 · 2 generations on4descendants
- K983342MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998 · 2 generations on4descendants
- K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931544 | 1.5T Edge and 1.0T Vista Systems | Philips Medical Systems (Cleveland), Inc. | 1993 | 2 |
| −1 | K954646 | Epi-II System Option W/High Performance Gradients | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K964626 | Edge/Vista System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| +1 | K974844 | Outlook System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| +2 | K013858 | Infinion 0.6T MR Imaging System | Philips Medical Systems (Cleveland), Inc. | 2002 | 2 |
| +2 | K024042 | Panorama Enhancements | Philips Medical Systems, Inc. | 2003 | — |
| +2 | K983342 | MR Guided Procedures (MRGP) Basic Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| +3 | K071154 | Superstar 0.35T Mri System | Neusoft Medical Systems Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K931544 | 1.5T Edge and 1.0T Vista SystemsSummary page 2…other MR, CT, Nuclear, workstation systems and cameras. Optional packages available for increased image reconstruction rates. ? ITEM EDGE/VISTA with System EDGE/VISTA (K931544) & Enhancement Package High Performance Gradients Option (K954646) Computer Subsystem Similar display/database Display/Database c… | 1993 |
| * | K954646 | Epi-II System Option W/High Performance GradientsSummary page 2…packages available for increased image reconstruction rates. ? ITEM EDGE/VISTA with System EDGE/VISTA (K931544) & Enhancement Package High Performance Gradients Option (K954646) Computer Subsystem Similar display/database Display/Database computer and scan reconstruction hardware connected together by a… | 1996 |
| † | K932693 | Edge System | 1993 |
| † | K941996 | EDGE | 1994 |
| † | K944469 | General Purpose Flex Coil | 1995 |
| † | K952530 | Head/Neck Vascular Phased Array Coil Package | 1995 |
| † | K962117 | Quadrature and Phased Array Flexible Body Coils | 1996 |
| † | K963356 | Phased Array Shoulder Coil | 1996 |
| † | K945397 | Angio II | 1995 |
| † | K945828 | Echo Planar Imaging I | 1995 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2013 | Class II | Z-0033-2014 | Device Design | There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system. |
| Sep 19, 2008 | Not classified | Z-2431-2010 | Other | Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite. |
| Sep 19, 2008 | Not classified | Z-2429-2010 | Other | Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite. |
| Sep 19, 2008 | Not classified | Z-2430-2010 | Other | Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K974844 (Philips Medical Systems (Cleveland), Inc., 1998) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K931544.
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?
The Picker International EDGE and VISTA systems are indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
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/K964626 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964626: Edge/Vista System Enhancement Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964626
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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