Cleared Abbreviated

K213583 - Achieva

K213583 is the FDA 510(k) clearance for Achieva by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code LNH) cleared through the Abbreviated 510(k) pathway after a 185-day FDA review.

K213583 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
185d
Days
Class 2
Risk

K213583 is an FDA 510(k) clearance for the Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on May 16, 2022 after a review of 185 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K213583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2021
Decision Date May 16, 2022
Days to Decision 185 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 107d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

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 Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K213583.
MAGNETOM Free.Max, MAGNETOM Free.Star
K220575 · Siemens Medical Solutions USA, Inc. · Jun 2022
Swoop Portable MR Imaging System
K221393 · Hyperfine, Inc. · Jun 2022
AIR Recon DL
K213717 · Ge Medical Systems,Llc (Ge Healthcare) · Jun 2022
MAGNETOM Skyra Fit
K220589 · Siemens Medical Solutions USA, Inc. · May 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
K220939 · Siemens Medical Solutions USA, Inc. · Apr 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K220192 · Canon Medical Systems Corporation · Apr 2022