510(k) · Cleared
ClearedrTOP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roclub GmbH · LLZ System, Image Processing, Radiological
Cleared on Feb 4, 2025 as substantially equivalent to K232744 (Siemens Healthcare GmbH, 2023) after a 103-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Feb 4, 2025
- Review
- 103 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K971684 (1997). 30 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 5 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 3 generations backK061449 Syngo Expert-1Siemens Medical Solution · 2006
- 2 generations backK150193 Customer Remote Console (CRC)Ge Medical Systems, LLC · 2015
- 1 generation backK232744 syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023
- This deviceK243333 rTOPRoclub GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −6 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −5 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −4 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −3 | K061449 | Syngo Expert-1 | Siemens Medical Solution | 2006 | — |
| −2 | K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | 2015 | — |
| −1 | K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | 2023 | — |
| 0 (this device) | K243333 | rTOP | Roclub GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 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 21.6 · 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 |
|---|---|---|---|
| * | K232744 | syngo Virtual Cockpit (VB10A)Summary page 5…iology Predicate Device Information Predicate Device Name syngo Virtual Cockpit (VB10A) Predicate Device K Number K232744 Product Code LLZ 510(k) Summary… | 2023 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 30 ancestors have a recall of any class.
- 3 other devices also cite its predicate K232744.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
roclub TeleOperationPlatform (rTOP) is a system (software application and hardware component) intended for remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical…
Read the full statement (124 words)
roclub TeleOperationPlatform (rTOP) is a system (software application and hardware component) intended for remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical personnel working on the medical imaging devices. Other medical devices, especially therapeutic devices (e.g. radiotherapeutic devices, …) with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device) may be used read only.
rTOP is not indicated for any specific disease, or condition.
rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243333 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243333: rTOP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243333
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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