510(k) · Cleared
ClearedBiopSee, Mobile US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcom GmbH · LLZ System, Image Processing, Radiological
Cleared on Jul 26, 2017 as substantially equivalent to K052379 (Mimvista Corp., 2005) and 3 other predicates after a 127-day review. Its family tree reaches back 19 generations to 1995. 1 of the 259 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 26, 2017
- Review
- 127 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K935595 (1995). 258 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet. 1 of the 259 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- 2 generations backK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
- 1 generation backK163119 NaviSuite SSI EditionMedcom GmbH · 2017
- This deviceK170841 BiopSee, Mobile USMedcom GmbH · 2017
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 10 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 9 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 7 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 6 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 5 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 4 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 3 generations backK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- 2 generations backK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
- 1 generation backK163119 NaviSuite SSI EditionMedcom GmbH · 2017
- This deviceK170841 BiopSee, Mobile USMedcom GmbH · 2017
Class I recalls in this family
- K070106 VV Fluoro 3D5 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −10 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −9 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −7 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −6 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −5 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −4 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −3 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
| −2 | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016 | — |
| −1 | K163119 | NaviSuite SSI Edition | Medcom GmbH | 2017 | — |
| 0 (this device) | K170841 | BiopSee, Mobile US | Medcom GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 11 | 0 |
| 1999 | 17 | 0 |
| 2000 | 18 | 0 |
| 2001 | 17 | 0 |
| 2002 | 18 | 0 |
| 2003 | 22 | 0 |
| 2004 | 21 | 0 |
| 2005 | 21 | 0 |
| 2006 | 15 | 0 |
| 2007 | 5 | 1 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K052379 | Mim 3.5 (Circa)Summary page 5…Page 7 of 54 C. Predicate Devices BiopSee: Device trade name: MIM 3.5 (CIRCA) 510(k) number: K052379 Company name: MIMVISTA CORP. Classification Number: 892.2050 Classi… | 2005 |
| * | K153073 | UroNav (Version 2.0)Summary page 5…lass II Product code: LLZ Device trade name: UroNav Fusion Biopsy System 510(k) number: K153073 Company name: Philips Medical Systems International BV Classification Number: 89… | 2015 |
| * | K163119 | NaviSuite SSI Edition Cleared while this submission was under review Summary page 5…Class II Product code: LLZ Device trade name: NaviSuite SSI Edition 510(k) number: K163119 Company name: MedCom GmbH. Classification Number: 892.2050 Classifi… | 2017 |
| * | K112420 | Oncentra Prostate 4.0Summary page 5…ion: Class II Product code: LLZ Device trade name: Oncentra Prostate 4.0 510(k) number: K112420 Company name: Nucletron Corporation Classification Number: 892.5700… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 5 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 56 of the 258 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K052379.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 BiopSee bundled system is a combination of MobileUS providing the “Medical Image Processing Workstation” which acquires and displays ultrasound images from external ultrasound scanners and the BiopSee “Image Fusion Navigation Software” which is a stereotaxic accessory for Ultrasound (US) devices. The BiopSee system is intended to be used in clinical interventions and for anatomical structures in a clinical setting where US imaging is currently used…
Read the full statement (212 words)
The BiopSee bundled system is a combination of MobileUS providing the “Medical Image Processing Workstation” which acquires and displays ultrasound images from external ultrasound scanners and the BiopSee “Image Fusion Navigation Software” which is a stereotaxic accessory for Ultrasound (US) devices.
The BiopSee system is intended to be used in clinical interventions and for anatomical structures in a clinical setting where US imaging is currently used for visualizing such procedures. It displays the simulated image of a tracked insertion tool such as a biopsy needle on a computer monitor that shows images of the target organs and the current and the projected future path of the interventional instrument.
The patient population is mainly people who need prostate biopsy.
It is intended to be used mainly in the Urological departments for prostate biopsies.
The BiopSee system is not intended to be used as a standalone diagnostic image device, since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always be seen as an additional source of information.
The BiopSee system when connected with an electromagnetic tracker should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
BiopSee is a prescription device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170841: BiopSee, Mobile US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170841
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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