ImmersiveView Surgical Plan (IVSP®)
FDA 510(k) K181813 · Immersivetouch
510(k) numberK181813
Submission
- Device name
- ImmersiveView Surgical Plan (IVSP®)
- Applicant
- Immersivetouch
Westmont, IL, US - Received
- July 6, 2018
- Decision date
- June 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 3D Systems, Inc. | 06/03/2026SE |
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| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
More from Centermed, Inc.
Questions and answers
When was ImmersiveView Surgical Plan (IVSP®) cleared by the FDA?
ImmersiveView Surgical Plan (IVSP®) (K181813) received a 510(k) decision of Substantially Equivalent on June 9, 2020, 704 days after the submission was received.
What is the product code of K181813?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.