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FDA 510(k)

ImmersiveView Surgical Plan (IVSP®)

K-Number: K181813 · 2020-06-09

ApplicantImmersivetouch
Decision Date2020-06-09
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ImmersiveView Surgical Plan (IVSP®) is the device name listed in this FDA 510(k) record. The listed applicant is Immersivetouch. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K181813. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImmersiveView Surgical Plan (IVSP®)?

ImmersiveView Surgical Plan (IVSP®) is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Immersivetouch. The 510(k) number is K181813.

When did ImmersiveView Surgical Plan (IVSP®) receive FDA 510(k) clearance?

ImmersiveView Surgical Plan (IVSP®) received FDA 510(k) clearance on 2020-06-09, under 510(k) number K181813.

Who is the listed applicant for ImmersiveView Surgical Plan (IVSP®)?

The FDA 510(k) record lists Immersivetouch as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImmersiveView Surgical Plan (IVSP®)?

The FDA product code for ImmersiveView Surgical Plan (IVSP®) is DZJ.

Other records listing Immersivetouch as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230249IkshanaK210726ImmersiveTouch

Related Devices (Code: DZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NVK242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.K231520tmCMF SolutionTechmah CmfK230276TECHFIT DISRP® SystemTechfit Digital SurgeryK223024MedCAD AccuPlan SystemMedcad

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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