510(k) Report

510(k) · Cleared

Cleared

Philips Easyvision

K972103510(k) TraditionalCleared Sep 2, 199790-day reviewClass II21 CFR 892.2050

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

Philips Medical Systems North America, Inc. · LLZ System, Image Processing, Radiological

Cleared on Sep 2, 1997 as substantially equivalent to K921219 (Philips Medical Systems, Inc., 1994) and 5 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1991.

Decided
Sep 2, 1997
Review
90 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K913770 (1991). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestors1992: 2 other ancestorsK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 199619901992199419961998
Other ancestors, by generation 1 generation back: 4 other ancestors K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 19910
  1. Root · 2 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 1 generation backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. This deviceK972103 Philips EasyvisionPhilips Medical Systems North America, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−1K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
0 (this device)K972103Philips EasyvisionPhilips Medical Systems North America, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199420
FIG. 1 — Lineage of K972103, 1991–1997Source: 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), 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 LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K921219Philips Dci-SX
Summary page 1
…rkstation Option MR Cardiac Analysis Package Classification Name: Image Processing System (90 LLZ) Common/Usual Name: Workstation Predicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K92079…
Philips Medical Systems, Inc.1994—
*K960613GE Advantage Windows Review Workstation
Summary page 1
…fication Name: Image Processing System (90 LLZ) Common/Usual Name: Workstation Predicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K920791) Intended Use: The MR Cardiac Analysis Package…
GE Medical Systems1996—
*K942120Advantage Windows Diagnostic X-Ray Workstation
Summary page 1
…Name: Image Processing System (90 LLZ) Common/Usual Name: Workstation Predicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K920791) Intended Use: The MR Cardiac Analysis Package is intend…
GE Medical Systems1994—
*K913770Advantage V.S. CT/MR Rad Diagnostic Workstation
Summary page 1
…rocessing System (90 LLZ) Common/Usual Name: Workstation Predicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K920791) Intended Use: The MR Cardiac Analysis Package is intended for use in…
General Electric Co.1991—
*K920578Philips Gyroscan T5 Series II
Summary page 1
…orkstation Predicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K920791) Intended Use: The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR image…
Philips Medical Systems North America, Inc.1992—
*K920791Gyroscan S15/Acs-II
Summary page 1
…redicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K920791) Intended Use: The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR images, resulting…
Philips Medical Systems, Inc.1992—

Also cleared against K921219: 1 other device →

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?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
  • None of the 6 ancestors has a recall.
  • 1 other device also cites its predicate K921219.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

The MR Cardiac Analysis Package is indicated for use in association with cardiac and

cardiovascular examinations where it is useful or necessary to perform qualitative or

quantitative analysis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K921219

1 other device cites the same predicate.

  • K971965Philips EasyvisionPhilips Medical Systems, Inc. · 1998

More from Philips Medical Systems North America…

71 FDA decisions under this applicant name. See the company

  • K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 201039 recalls
  • K062233Heartstart MRX Monitor/DefibrillatorPhilips Medical Systems North America, Inc. · 20062 Class I recalls
  • K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006
  • K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006
  • K050151Multidiagnost ElevaPhilips Medical Systems North America, Inc. · 200521 recalls

Recent decisions in LLZ

The LLZ category page

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  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
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https://510kreport.com/device/K972103 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972103: Philips Easyvision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972103

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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