510(k) · Cleared
ClearedNodecrest Transcranical Doppler Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nodecrest, LLC · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 5, 2006 as substantially equivalent to K974588 (Rimed, Ltd., 1998) after a 108-day review. Its family tree reaches back 1 generation to 1998. 8 later devices descend from it.
- Decided
- May 5, 2006
- Review
- 108 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974588 (1998). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974588 Intra-View Bilateral Transcranial Doppler Device, Smart-Lite…Rimed, Ltd. · 1998
- This deviceK060112 Nodecrest Transcranical Doppler Ultrasound SystemNodecrest, LLC · 2006
- Descendant · cites it directly · 7 of its ownK092164 Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers…Shenzhen Delicate Electronics Co., Ltd. · 2010
- Descendant · 2 generations on · 5 of its ownK122710 Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK173801 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK180455 NeuralBotNeural Analytics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK254143 EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K092164Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UAShenzhen Delicate Electronics Co., Ltd. · 2010 · cites it directly7descendants
- K122710Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013 · 2 generations on5descendants
- K173801Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2018 · 3 generations on2descendants
- K180455NeuralBotNeural Analytics, Inc. · 2018 · 3 generations on1descendant
- K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable… | Rimed, Ltd. | 1998 | — |
| 0 (this device) | K060112 | Nodecrest Transcranical Doppler Ultrasound System | Nodecrest, LLC | 2006 | — |
| +1 | K092164 | Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model… | Shenzhen Delicate Electronics Co., Ltd. | 2010 | — |
| +2 | K122710 | Transcranial Doppler with Robotic Probe Headband | Shenzhen Delicate Electronics Co., Ltd. | 2013 | — |
| +3 | K173801 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2018 | — |
| +3 | K180455 | NeuralBot | Neural Analytics, Inc. | 2018 | 1 |
| +2 | K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral…Summary page 2…Nodecrest Rimed Ltd. 510(k) Number K974588 Transducer Frequency 2MHz, 4MHz, 8MHz 2MHz, 4MHz, 8MHz Frequency Spec… | 1998 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092164 | Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UA | 2010 | 7 |
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 IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values 2) To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior…
Read the full statement (146 words)
The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a
diagnostic ultrasound fluid flow analysis system:
1) For the measurement of cerebral artery blood velocities to determine the
presence of hemodynamically significant deviations from normal values
2) To assess arterial cerebral blood flow for the occurrence of micro embolic
signals. Vessels intended for observation include, but are not limited to the
middle, anterior and posterior cerebral arteries, via the temporal windows, the
vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery
and intracranial internal carotid artery via the eye.
The Nodecrest Transcranial Doppler is intended for use during:
a) Diagnostic exams
b) Surgical interventions
The device is not intended to replace other means of evaluating vital patient physiological
processes, is not intended to be used in fetal applications, and is not intended to be used
inside the sterile field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060112: Nodecrest Transcranical Doppler Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060112
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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