Synapsys VHIT
FDA 510(k) K242726 · Inventis S.R.L.
510(k) numberK242726
Submission
- Device name
- Synapsys VHIT
- Applicant
- Inventis S.R.L.
Padova, IT - Received
- September 10, 2024
- Decision date
- January 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K260566 | SMARTVERTIGO Vestibular Assessment SystemGWN · Traditional | VertigoDx, Inc. | 07/30/2026SE |
| K243709 | NeuroEars-AnnaGWN · Traditional | Neuroears, Inc. | 08/25/2025SE |
| K242198 | ICS Dizcovery (1091)GWN · Traditional | Natus Medical Denmark Aps | 02/14/2025SE |
| K223047 | NeuroSwift ProGWN · Traditional | Neurobit Technologies Co., Ltd. | 06/29/2023SE |
| K203082 | Insight Infrared Video GogglesGWN · Traditional | Vestibular First | 11/12/2020SE |
| K200534 | VisualEyesGWN · Traditional | Interacoustics A/S | 08/12/2020SE |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…GWN · Traditional | Neurolign USA, LLC | 11/29/2019SE |
| K181771 | RightEye Vision SystemGWN · Traditional | Righteye, LLC | 09/28/2018SE |
| K182214 | DizzyDoctor System 1.0.0GWN · Traditional | Dizzydoctor Systems, LLC | 09/14/2018SE |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal…GWN · Special | Neuro Kinetics, Inc. | 07/24/2018SE |
More from Neuro Kinetics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133013 | Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus…ETY · Traditional | 01/24/2014SE |
Questions and answers
When was Synapsys VHIT cleared by the FDA?
Synapsys VHIT (K242726) received a 510(k) decision of Substantially Equivalent on January 3, 2025, 115 days after the submission was received.
What is the product code of K242726?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.