510(k) · Cleared
Recalled · Class II · 2024NovaGuide 2 Intelligent Ultrasound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novasignal Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 2, 2022 as substantially equivalent to K180455 (Neural Analytics, Inc., 2018) after a 152-day review. Its family tree reaches back 5 generations to 1998. It has been recalled 2 times.
- Decided
- Mar 2, 2022
- Review
- 152 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974588 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK974588 Intra-View Bilateral Transcranial Doppler Device, Smart-Lite…Rimed, Ltd. · 1998
- 4 generations backK060112 Nodecrest Transcranical Doppler Ultrasound SystemNodecrest, LLC · 2006
- 3 generations backK092164 Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers…Shenzhen Delicate Electronics Co., Ltd. · 2010
- 2 generations backK122710 Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013
- 1 generation backK180455 NeuralBotNeural Analytics, Inc. · 2018 · Recalled
- This deviceK213279 NovaGuide 2 Intelligent UltrasoundNovasignal Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable… | Rimed, Ltd. | 1998 | — |
| −4 | K060112 | Nodecrest Transcranical Doppler Ultrasound System | Nodecrest, LLC | 2006 | — |
| −3 | 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 | — |
| −1 | K180455 | NeuralBot | Neural Analytics, Inc. | 2018 | 1 |
| 0 (this device) | K213279 | NovaGuide 2 Intelligent Ultrasound | Novasignal Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K180455 | NeuralBotSummary page 4…er, Robotic (21 CFR 892.1570) Product Codes: IYN, ITX, OQQ 7.3 Predicate Device Primary Predicate Device: NeuralBot, NovaSignal Corporation (K180455) Reference Device: Lucid M1 Transcranial Doppler Ultrasound System, NovaSignal Corporation (K160442) 7.4 Dev… | 2018 |
| † | K160442 | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2024 | Class II | Z-2216-2024 | Device Design | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction. |
| May 6, 2024 | Class II | Z-2217-2024 | Device Design | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 7 ancestors have a recall of any class.
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. 2022, this device’s year, is highlighted.
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?
NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. NovaGuide 2 Intelligent Ultrasound is intended to be used by healthcare…
Read the full statement (112 words)
NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows.
NovaGuide 2 Intelligent Ultrasound is intended to be used by healthcare professionals qualified by training in its safe and effective use. 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 as stated in the FDA summary.
https://510kreport.com/device/K213279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213279: NovaGuide 2 Intelligent Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213279
Report an extraction error
Are you the manufacturer?
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