510(k) · Cleared
ClearedTargetscn Transrectal Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisioneering, LLC · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 2, 2004 as substantially equivalent to K864807 (Teknar, Inc., 1987) after a 77-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.
- Decided
- Sep 2, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864807 (1987). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK864807 Teknar Proscan (TM)Teknar, Inc. · 1987
- This deviceK041639 Targetscn 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 · 4 generations on · 1 of its ownK213411 iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021
- Descendant · 5 generations on · 0 of its ownK232320 iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · 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
- K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2021 · 4 generations on1descendant
- K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864807 | Teknar Proscan (TM) | Teknar, Inc. | 1987 | — |
| 0 (this device) | K041639 | Targetscn 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 | — |
| +4 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | — |
| +5 | K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K864807 | Teknar Proscan (TM)Summary page 1…ce for the ultrasound probe and system is: Carolina Medical Proscan® and Proscarn® Plus Umrlogical Ultrasound Imaging systems (Teknar K(864807) 9. Device Description: The TargetScan Tm Transrectal Ultrasound system isintended for diagnostic prostate… | 1987 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111347 | Isrobot Mona Lisa | 2011 | 4 |
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?
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
This Ultrasound imaging system is intended for transrectal diagnostic imaging of the prostate gland. This imaging can be used to guide other procedures such as biopsy of the prostate.
This system is intended to be used with adult patients.
This system is intended for use by medical professionals in a physician office or hospital environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041639: Targetscn 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/K041639
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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