Cleared Traditional

AMRA Profiler (K173749) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173749 · Amra Medical AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
363d
Days
Class 2
Risk

K173749 is an FDA 510(k) clearance for the AMRA Profiler. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Amra Medical AB (Linkoping, SE). The FDA issued a Cleared decision on December 6, 2018 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amra Medical AB devices

Submission Details

510(k) Number K173749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2017
Decision Date December 06, 2018
Days to Decision 363 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 107d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Licensale, Inc.
Raymond Kelly

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 486
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K173749.
SIGNA Premier
K183231 · Ge Medical Systems, LLC · Jan 2019
Magnetom Vida
K183254 · Siemens Medical Solutions USA, Inc. · Jan 2019
uMR 580, uMR 588
K183137 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2019
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
K181613 · Siemens Medical Solutions USA, Inc. · Nov 2018
MAGNETOM Aera
K182299 · Siemens Medical Solutions USA, Inc. · Oct 2018
MAGNETOM Vida
K181433 · Siemens Medical Solutions USA, Inc. · Oct 2018