510(k) · Cleared
ClearedTargetscan Transrectal Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisioneering, LLC · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 1, 2004 as substantially equivalent to K970514 (CIVCO Medical Instruments Co., Inc., 1997) after a 76-day review. Its family tree reaches back 2 generations to 1988. 8 later devices descend from it.
- Decided
- Sep 1, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K875128 (1988). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK875128 Trans/R Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- 1 generation backK970514 Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle…CIVCO Medical Instruments Co., Inc. · 1997 · Recalled
- This deviceK041637 Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC · 2004
- Descendant · cites it directly · 4 of its ownK111347 Isrobot Mona LisaBiobot Surgical Pte., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK130944 Isr'obot Mona LisaBiobot Surgical Pte., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK203659 iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK163502 iSR'obot Biopsy KitBiobot Surgical Pte., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K111347Isrobot Mona LisaBiobot Surgical Pte., Ltd. · 2011 · cites it directly4descendants
- K130944Isr'obot Mona LisaBiobot Surgical Pte., Ltd. · 2013 · 2 generations on3descendants
- K203659iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd. · 2021 · 3 generations on2descendants
- K163502iSR'obot Biopsy KitBiobot Surgical Pte., Ltd. · 2017 · cites it directly2descendants
- K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875128 | Trans/R Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −1 | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… | CIVCO Medical Instruments Co., Inc. | 1997 | 3 |
| 0 (this device) | K041637 | Targetscan Transrectal Ultrasound System | Envisioneering, LLC | 2004 | — |
| +1 | K111347 | Isrobot Mona Lisa | Biobot Surgical Pte., Ltd. | 2011 | — |
| +2 | K130944 | Isr'obot Mona Lisa | Biobot Surgical Pte., Ltd. | 2013 | — |
| +3 | K203659 | iSR'obot Mona Lisa 1.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +1 | K163502 | iSR'obot Biopsy Kit | Biobot Surgical Pte., Ltd. | 2017 | — |
| +2 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument GuideSummary page 1…570; Procode ITX) 8. Identification of Predicate Device(s): The predicate device for the biopsy needle guide is: . Civco Transrectal Needle Guide (K970514) 9. Device Description: The sterile TargetScan TM Biopsy needle Guide is designed to be used with the… | 1997 |
What descends from it? (8)
3 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 16 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K111347 (Biobot Surgical Pte., Ltd., 2011) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K970514.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan model TS-360-P probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041637: Targetscan Transrectal Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041637
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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