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510(k) K251029

Vista OS, Vista AI Scan, RTHawk by Vista AI, Inc. — Product Code LNH

K251029 is an FDA 510(k) premarket notification submitted by Vista AI, Inc. for the device "Vista OS, Vista AI Scan, RTHawk". The FDA issued a decision of Substantially Equivalent on August 21, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2025
Date Received
April 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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FDA data resources