510(k) · Cleared
ClearedInvision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inneroptic Technology, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 12, 2009 as substantially equivalent to K974432 (Ultraguide, Ltd., 1998) and 3 other predicates after a 239-day review. Its family tree reaches back 2 generations to 1988. 8 later devices descend from it.
- Decided
- Aug 12, 2009
- Review
- 239 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K882383 (1988). 14 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- 1 generation backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- This deviceK083728 Invision SystemInneroptic Technology, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK121479 AIMInneroptic Technology, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK141806 Clear Guide OneClear Guide Medical · 2014
- Descendant · 2 generations on · 1 of its ownK132744 Acessa Guidance SystemHalt Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK101979 Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK211529 NAVIRFA ScopeNavifus Corporation · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K121479AIMInneroptic Technology, Inc. · 2012 · cites it directly5descendants
- K141806Clear Guide OneClear Guide Medical · 2014 · 2 generations on2descendants
- K132744Acessa Guidance SystemHalt Medical, Inc. · 2014 · 2 generations on1descendant
- K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc. · 2011 · cites it directly1descendant
- K211529NAVIRFA ScopeNavifus Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −1 | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| 0 (this device) | K083728 | Invision System | Inneroptic Technology, Inc. | 2009 | — |
| +1 | K121479 | AIM | Inneroptic Technology, Inc. | 2012 | — |
| +2 | K141806 | Clear Guide One | Clear Guide Medical | 2014 | — |
| +2 | K132744 | Acessa Guidance System | Halt Medical, Inc. | 2014 | — |
| +1 | K101979 | Explorer Liver (Passive Tracking) | Pathfinder Therapeutics, Inc. | 2011 | — |
| +3 | K211529 | NAVIRFA Scope | Navifus Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K974432 | Ultraguide 1000Summary page 2…Code [YO: system, imaging, Ultraguide 1000 ulsed echo, ultrasonic K974432 JAK: system, x-ray, IG4 Image Guided System tomography, compute K0… | 1998 |
| * | K060903 | IG4 Image Guided SystemSummary page 2…ulsed echo, ultrasonic K974432 JAK: system, x-ray, IG4 Image Guided System tomography, compute K060903 Linasys Image-Guided Liver Surgery OEW: tracking, soft 071063 System tissue, intra… | 2006 |
| * | K071063 | LinasysSummary page 2…JAK: system, x-ray, IG4 Image Guided System tomography, compute K060903 Linasys Image-Guided Liver Surgery OEW: tracking, soft 071063 System tissue, intraoperative Karl Storz 3D Video System GCL laryngoscope,… | 2007 |
| * | K001362 | Karl Storz 3D Video SystemSummary page 2…OEW: tracking, soft 071063 System tissue, intraoperative Karl Storz 3D Video System GCL laryngoscope, 001362 endoscope The device labeling contains instructions for use, including indications for us… | 2000 |
What descends from it? (8)
2 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 21 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K121479 (Inneroptic Technology, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K974432.
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. 2009, 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 InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083728: Invision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083728
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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