REMEDY LOGIC

FDA Device Registration & Listing · New York, NY, US · Registration 3042852277

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042852277
FEI Number
3042852277
Entity Name
REMEDY LOGIC
City/State/Country
New York, NY, US
Establishment Address
6 Saint Johns Ln, New York, NY 10013, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Remedy Logic (Owner Number: 10094872)
Owner / Operator Contact Address
6 St Johns ln, New York, NY 10013, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241108
PMA Number
N/A

All Registered Proprietary Names

RemedyLogic AI MRI Lumbar Spine Reader

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-12-30

Official Correspondent

Andrej Rusakov

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Remedy Logic
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042852277. Last updated year: 2026. Please use registration number 3042852277 when referencing this establishment in official correspondence.
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