InVision™ 1.5 Surgical Theatre

FDA 510(k) K240157 · Deerfield Imaging, Inc.

Substantially Equivalent

510(k) numberK240157

Submission

Device name
InVision™ 1.5 Surgical Theatre
Applicant
Deerfield Imaging, Inc.
Chaska, MN, US
Received
January 19, 2024
Decision date
February 15, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

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Questions and answers

When was InVision™ 1.5 Surgical Theatre cleared by the FDA?

InVision™ 1.5 Surgical Theatre (K240157) received a 510(k) decision of Substantially Equivalent on February 15, 2024, 27 days after the submission was received.

What is the product code of K240157?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.