510(k) Report

510(k) · Cleared

Cleared

Vistar

K905070510(k) TraditionalCleared Jan 2, 199154-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems (Cleveland), Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jan 2, 1991 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 166 later devices descend from it.

Decided
Jan 2, 1991
Review
54 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

166 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1997: 2 descendants cleared1999: 7 descendants cleared1998: 1 descendant cleared2009: 3 descendants cleared2021: 10 descendants cleared2001: 1 descendant cleared2003: 2 descendants cleared2004: 1 descendant cleared2008: 2 descendants cleared2005: 1 descendant cleared2012: 4 descendants cleared2006: 1 descendant cleared2014: 2 descendants cleared2010: 1 descendant cleared2015: 6 descendants cleared2016: 5 descendants cleared2013: 3 descendants cleared2017: 11 descendants cleared2019: 10 descendants cleared2018: 2 descendants cleared2020: 12 descendants cleared2025: 18 descendants cleared2022: 14 descendants cleared2023: 20 descendants cleared2024: 14 descendants cleared2026: 11 descendants cleared1990200020102020
  1. This deviceK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
  2. Descendant · cites it directly · 161 of its ownK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
  3. Descendant · 2 generations on · 160 of its ownK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
  4. Descendant · 2 generations on · 159 of its ownK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
  5. Descendant · 3 generations on · 152 of its ownK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
  6. Descendant · 4 generations on · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001

Showing 5 of 166 descendants. See all descendants

Descendants cleared per year

1996: 21997: 21998: 11999: 72001: 12003: 22004: 12005: 12006: 12008: 22009: 32010: 12012: 42013: 32014: 22015: 62016: 52017: 112018: 22019: 102020: 122021: 102022: 142023: 202024: 142025: 182026: 11
1996high 20 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 166 · See all
  • K961168ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996 · cites it directly161descendants
  • K963221Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997 · 2 generations on160descendants
  • K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997 · 2 generations on159descendants
  • K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999 · 3 generations on152descendants
  • K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · 4 generations on151descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905070VistarPhilips Medical Systems (Cleveland), Inc.1991—
+1K961168ViewpointPhilips Medical Systems (Cleveland), Inc.1996—
+2K963221Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc.1997—
+2K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc.1997—
+3K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc.1999—
+4K013025Modification to Flourolab PlusZ-Kat, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199720
199810
199970
200110
200320
200410
200510
200610
200820
200930
201010
201240
201330
201420
201560
201650
2017110
201820
2019100
2020120
2021100
2022140
2023200
2024140
2025180
2026110
FIG. 1 — Lineage of K905070, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (166)

See all 166

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961168ViewpointPhilips Medical Systems (Cleveland), Inc.1996161
K961637Picker MR Workstations (Vistar,Montage and Oncall)Philips Medical Systems (Cleveland), Inc.19963

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?

  • Of its descendants, K961168 (Philips Medical Systems (Cleveland), Inc., 1996) has gone furthest, with 161 descendants of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

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https://510kreport.com/device/K905070 · printed Nov 5, 2026

Cite this page

510(k) Report. “K905070: Vistar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K905070

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026