510(k) · Cleared
ClearedCustomer Remote Console (CRC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LLZ System, Image Processing, Radiological
Cleared on Mar 24, 2015 as substantially equivalent to K052423 (Siemens Medi Cal Solutions, Inc., 2006) and 2 other predicates after a 55-day review. Its family tree reaches back 5 generations to 1997. 12 later devices descend from it.
- Decided
- Mar 24, 2015
- Review
- 55 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K971684 (1997). 28 ancestors in all, the oldest K871859 (1987). 12 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 3 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 2 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 1 generation backK061449 Syngo Expert-1Siemens Medical Solution · 2006
- This deviceK150193 Customer Remote Console (CRC)Ge Medical Systems, LLC · 2015
- Descendant · cites it directly · 4 of its ownK232744 syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023
- Descendant · cites it directly · 4 of its ownK200179 Collaboration LivePhilips Health Care · 2020
- Descendant · 2 generations on · 2 of its ownK201665 Collaboration LivePhilips Ultrasound, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK212777 Collaboration LivePhilips Ultrasound, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK243666 uOmniscanShanghai United Imaging Healthcare Co., Ltd. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023 · cites it directly4descendants
- K200179Collaboration LivePhilips Health Care · 2020 · cites it directly4descendants
- K201665Collaboration LivePhilips Ultrasound, Inc. · 2020 · 2 generations on2descendants
- K212777Collaboration LivePhilips Ultrasound, Inc. · 2021 · 3 generations on1descendant
- K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −4 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −3 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −2 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −1 | K061449 | Syngo Expert-1 | Siemens Medical Solution | 2006 | — |
| 0 (this device) | K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | 2015 | — |
| +1 | K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | 2023 | — |
| +1 | K200179 | Collaboration Live | Philips Health Care | 2020 | — |
| +2 | K201665 | Collaboration Live | Philips Ultrasound, Inc. | 2020 | — |
| +3 | K212777 | Collaboration Live | Philips Ultrasound, Inc. | 2021 | — |
| +2 | K243666 | uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052423 | Magnetom Systems with Syngo Expert - I OptionSummary page 5…CFR 892.2050 Picture archiving and communication system Product Code: 90 LLZ Predicate Device: MAGNETOM Systems with syngo Expert-i option (K052423) SYNGO EXPERT-I (K061449) AW Server (K081985)… | 2006 |
| * | K061449 | Syngo Expert-1Summary page 5…m Product Code: 90 LLZ Predicate Device: MAGNETOM Systems with syngo Expert-i option (K052423) SYNGO EXPERT-I (K061449) AW Server (K081985) Page 5 - 2 Dev… | 2006 |
| * | K081985 | AW ServerSummary page 5…Predicate Device: MAGNETOM Systems with syngo Expert-i option (K052423) SYNGO EXPERT-I (K061449) AW Server (K081985) Page 5 - 2 Device Description: Cu… | 2008 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 28 ancestors have a recall of any class.
- Of its descendants, K232744 (Siemens Healthcare GmbH, 2023) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K052423.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Customer Remote Console Software Option allows remote access for viewing/review of images as well as the ability to remotely provide real time guidance to the technologist operating GE Healthcare medical imaging devices. This access must be granted by the technologist operating the system. The remote access is only available for systems supporting GE remote connectivity capability. Images reviewed remotely are not for diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150193: Customer Remote Console (CRC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150193
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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