ImmersiveTouch

FDA 510(k) K210726 · Immersivetouch, Inc.

Substantially Equivalent

510(k) numberK210726

Submission

Device name
ImmersiveTouch
Applicant
Immersivetouch, Inc.
Chicago, IL, US
Received
March 11, 2021
Decision date
September 29, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was ImmersiveTouch cleared by the FDA?

ImmersiveTouch (K210726) received a 510(k) decision of Substantially Equivalent on September 29, 2021, 202 days after the submission was received.

What is the product code of K210726?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.