RemedyLogic AI MRI Lumbar Spine Reader— 510(k) K241108

Substantially Equivalent

Remedy Logic, Inc.

FDA 510(k) clearance K241108 for RemedyLogic AI MRI Lumbar Spine Reader, Substantially Equivalent on 2024-10-30. Applicant: Remedy Logic, Inc.. Device class: 2.

Clearance details

Applicant
Remedy Logic, Inc.
Product code
Code QIH
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
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