510(k) · Cleared
ClearedExactVu High Resolution Micro-Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exact Imaging, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 30, 2018 as substantially equivalent to K162972 (Exact Imaging, 2016) after a 49-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 30, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000567 (2000). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
- 4 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- 3 generations backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
- 2 generations backK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
- 1 generation backK162972 ExactVu High Resolution Micro-Ultrasound SystemExact Imaging · 2016
- This deviceK180636 ExactVu High Resolution Micro-Ultrasound SystemExact Imaging, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK190995 ExactVu High Resolution Micro-Ultrasound SystemExact Imaging, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK192303 ExactVu High Resolution Micro-Ultrasound SystemExact Imaging, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | 2000 | 1 |
| −4 | K024236 | Ultrasound Scanner, Type 2400 | B-K Medical A/S | 2003 | 2 |
| −3 | K043524 | Ultrasound Scanner Pro Focus, Model 2202 | B-K Medical A/S | 2005 | 1 |
| −2 | K081154 | Ultrasound Scanner Flex Focus, Model 1202 | B-K Medical Aps | 2008 | — |
| −1 | K162972 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging | 2016 | — |
| 0 (this device) | K180636 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | 2018 | — |
| +1 | K190995 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | 2019 | — |
| +2 | K192303 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K162972 | ExactVu High Resolution Micro-Ultrasound SystemSummary page 4…l vessel Other (spec.) Dermatology N= new indication; P= previously cleared ; E= added under this appendix All items marked “P” were previously cleared by 510(k) number K162972. Additional Comments: 1. Includes imaging to assist in the placement of needles for prostate biopsy procedures. 2. Includes a… | 2016 |
| † | K170521 | Trinity/3D Prostate Suite | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190995 | ExactVu High Resolution Micro-Ultrasound System | 2019 | 1 |
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 5 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K190995 (Exact Imaging, Inc., 2019) has gone furthest, with 1 descendant of its own.
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. 2018, this device’s year, is highlighted.
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?
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use are:
Small Organ (prostate)
Transrectal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180636: ExactVu High Resolution Micro-Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180636
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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