Cleared Traditional

K052013 - ACHIEVA 1.5T & INERA 1.5T FAMILY

K052013 is the FDA 510(k) clearance for ACHIEVA 1.5T & INERA 1.5T FAMILY by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K052013 · Philips Medical Systems Nederland B.V. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2005
Decision
7d
Days
Class 2
Risk

K052013 is an FDA 510(k) clearance for the ACHIEVA 1.5T & INERA 1.5T FAMILY. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Bothell, US). The FDA issued a Cleared decision on August 2, 2005 after a review of 7 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K052013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date August 02, 2005
Days to Decision 7 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 107d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
MARC M MOUSER

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

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