510(k) Report

510(k) · Cleared

Cleared

Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS

K123426510(k) TraditionalCleared Mar 1, 2013114-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

Orpheus Medical, Ltd. · LLZ System, Image Processing, Radiological

Cleared on Mar 1, 2013 as substantially equivalent to K043324 (KARL STORZ Endoscopy-America, Inc., 2005) and 2 other predicates after a 114-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.

Decided
Mar 1, 2013
Review
114 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K931783 (1993). 49 ancestors in all, the oldest K801623 (1980). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2005: 2 other ancestors2002: 2 other ancestors1997: 7 other ancestors2004: 1 other ancestor2001: 1 other ancestor1995: 10 other ancestors1993: 2 other ancestors1998: 2 other ancestors1996: 5 other ancestors1994: 1 other ancestor1991: 3 other ancestors1992: 1 other ancestor1988: 1 other ancestor1980: 1 other ancestor2016: 1 descendant clearedK931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996×2: 2 generations cleared close together, K973700 (1998), K980787 (1998) ×2: 2 generations cleared close together, K990691 (1999), K991444 (1999) K022393 · Merdoc System · Stryker Endoscopy · 2003K033132 · Stryker Switchpoint Infinity · Stryker Communications Corp. · 2004 · recalledK100852 · Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 · Stryker Communications · 201019801990200020102020
  1. Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 5 generations between
  3. 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
  4. 2 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
  5. 1 generation backK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
  6. This deviceK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
  7. Descendant · cites it directly · 0 of its ownK151737 MedicVOD SystemOrpheus Medical, Ltd. · 2016
Show all 9 generations
  1. Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
  4. 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
  5. 5 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
  6. 4 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
  7. 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
  8. 2 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
  9. 1 generation backK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
  10. This deviceK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K151737MedicVOD SystemOrpheus Medical, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−8K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
−7K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998—
−6K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998—
−5K990691Hermes Operating Room Control CenterComputer Motion, Inc.1999—
−4K991444Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).Computer Motion, Inc.1999—
−3K022393Merdoc SystemStryker Endoscopy2003—
−2K033132Stryker Switchpoint InfinityStryker Communications Corp.200411
−1K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications2010—
0 (this device)K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.2013—
+1K151737MedicVOD SystemOrpheus Medical, Ltd.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198810
199130
199210
199320
199410
1995100
199650
199770
199820
200110
200220
200410
200520
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K123426, 1993–2016Source: 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? (3)

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
*K043324Aida with Dicom and HL7 Interface
Summary page 4
….6 Regulation Number: 21 CFR 892.2050, 21 CFR 876.1500 . 3.7 Product Code: LLZ, KOG 4 PREDICATE DEVICE: ' 4.1 AIDA with DICOM and HL7 interface, by Storz, cleared under K043324 4.2 660 HD Image Management System, by Smith & Nephew, cleared under K080777 4.3 SwitchPoint Infinity®3 (SP13) Control System, b…
KARL STORZ Endoscopy-America, Inc.2005—
*K080770Imagenmd with Imagenq
Our OCR of the scanned summary read K080777, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “660 HD Image Management System”.
Cardiovascular Imaging Technologies, LLC2008—
*K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000
Summary page 4
…4.2 660 HD Image Management System, by Smith & Nephew, cleared under K080777 4.3 SwitchPoint Infinity®3 (SP13) Control System, by Stryker Communications, cleared under K100852 ‘ § DEVICE DESCRIPTION: _ 5.1 The MedicVOD System is a video system enabling medical teams to document, record and broadcast li…
Stryker Communications2010—

Also cleared against K043324: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K151737MedicVOD SystemOrpheus Medical, Ltd.20160

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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
  • 1 of the 49 ancestors has a recall of any class.
  • Of its descendants, K151737 (Orpheus Medical, Ltd., 2016) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K043324.

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. 2013, this device’s year, is highlighted.

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 MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with video-conferencing capability during the broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.

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

Cite this page

510(k) Report. “K123426: Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123426

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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