510(k) · Cleared
ClearedMedicVOD System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orpheus Medical, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Feb 25, 2016 as substantially equivalent to K123426 (Orpheus Medical, Ltd., 2013) after a 244-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Feb 25, 2016
- Review
- 244 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931783 (1993). 50 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations between
- 3 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- 2 generations backK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
- 1 generation backK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
- This deviceK151737 MedicVOD SystemOrpheus Medical, Ltd. · 2016
Show all 10 generations
- Root · 10 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 9 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 8 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 7 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 6 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 5 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 4 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 3 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- 2 generations backK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
- 1 generation backK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
- This deviceK151737 MedicVOD SystemOrpheus Medical, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −9 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −8 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −7 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −6 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −5 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −4 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −3 | K033132 | Stryker Switchpoint Infinity | Stryker Communications Corp. | 2004 | 11 |
| −2 | K100852 | Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 | Stryker Communications | 2010 | — |
| −1 | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | Orpheus Medical, Ltd. | 2013 | — |
| 0 (this device) | K151737 | MedicVOD System | Orpheus Medical, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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 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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSSummary page 4…ystem is claimed to be substantially equivalent to the following legally marketed predicate device: 5.1.1 Orpheus Medical Ltd. MedicVOD System (K123426) 6. Performance Standards 6.1 There are no mandatory performance standards for this device. 7. Device Description… | 2013 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 50 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
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 as stated in the FDA summary.
https://510kreport.com/device/K151737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151737: MedicVOD System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151737
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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