510(k) Report

510(k) · Cleared

Cleared

Real-Time Video Contrast Enhancer

K962260510(k) TraditionalCleared Sep 9, 199689-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

Digivision, Inc. · LLZ System, Image Processing, Radiological

Cleared on Sep 9, 1996 as substantially equivalent to K864584 (Digivision, Inc., 1986) after an 89-day review. Its family tree reaches back 1 generation to 1986. 10 later devices descend from it.

Decided
Sep 9, 1996
Review
89 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K864584 (1986). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2026: 2 descendants cleared2022: 2 descendants cleared2024: 1 descendant cleared2023: 2 descendants clearedK864584 · Fluorovision Contrast Enhancer · Digivision, Inc. · 19861990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants K864584 · Fluorovision Contrast Enhancer · Digivision, Inc. · 19860+5
  1. Root · 1 generation backK864584 Fluorovision Contrast EnhancerDigivision, Inc. · 1986
  2. This deviceK962260 Real-Time Video Contrast EnhancerDigivision, Inc. · 1996
  3. Descendant · cites it directly · 9 of its ownK130929 Zmed VP4000Zmed, Inc. · 2013
  4. Descendant · 2 generations on · 8 of its ownK201434 Connected OR Hub with Voice Control, Connected OR Hub with Device…Stryker · 2020
  5. Descendant · 3 generations on · 6 of its ownK212055 Connected OR Hub with Device and Voice ControlStryker Corporation · 2021
  6. Descendant · 4 generations on · 5 of its ownK220108 SDC4K Information Management System with Device and Voice Control…Stryker Endoscopy · 2022
  7. Descendant · 4 generations on · 4 of its ownK222079 Connected OR Hub with Device and Voice Control, SDC4K Information…Stryker Endoscopy · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013: 12020: 12021: 12022: 22023: 22024: 12026: 2
2013high 2 (2022) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all
  • K130929Zmed VP4000Zmed, Inc. · 2013 · cites it directly9descendants
  • K201434Connected OR Hub with Voice Control, Connected OR Hub with Device ControlStryker · 2020 · 2 generations on8descendants
  • K212055Connected OR Hub with Device and Voice ControlStryker Corporation · 2021 · 3 generations on6descendants
  • K220108SDC4K Information Management System with Device and Voice Control PackageStryker Endoscopy · 2022 · 4 generations on5descendants
  • K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…Stryker Endoscopy · 2022 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864584Fluorovision Contrast EnhancerDigivision, Inc.1986—
0 (this device)K962260Real-Time Video Contrast EnhancerDigivision, Inc.1996—
+1K130929Zmed VP4000Zmed, Inc.2013—
+2K201434Connected OR Hub with Voice Control, Connected OR Hub with Device ControlStryker2020—
+3K212055Connected OR Hub with Device and Voice ControlStryker Corporation2021—
+4K220108SDC4K Information Management System with Device and Voice Control PackageStryker Endoscopy2022—
+4K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management…Stryker Endoscopy2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
202010
202110
202220
202320
202410
202620
FIG. 1 — Lineage of K962260, 1986–2026Source: 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), 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K864584Fluorovision Contrast Enhancer
Summary page 1
…VISION - FLUOROVISION COMMON NAME: VIDEO CONTRAST ENHANCER CLASSIFICATION NAME: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM (ACCESSORY) (PER 21 CFR 892.1650) 510K NUMBER K864584 PREPARED _ ) (/"€ 7/, 199¢, DATE 10K SUMMARY Description The CE-3000 takes a video signal in and allows an op…
Digivision, Inc.1986—

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130929Zmed VP4000Zmed, Inc.20139

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?

  • Its one ancestor has no recall.
  • Of its descendants, K130929 (Zmed, Inc., 2013) has gone furthest, with 9 descendants of its own.

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 CE-3000 Contrast Enhancer like the FluoroVision, may be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy. Despite the different indication statements, both devices have the same function and purpose and the differences in intended use does not create new safety or effectiveness issues.

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

More from Digivision, Inc.

4 FDA decisions under this applicant name. See the company

  • K895320Fluorovision HR 2000 High Resolution Image EnhanceDigivision, Inc. · 1989
  • K873646DigiviewerDigivision, Inc. · 1987
  • K864584Fluorovision Contrast EnhancerDigivision, Inc. · 1986

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K962260 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962260: Real-Time Video Contrast Enhancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962260

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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