Cleared Traditional

K990335 - PHILIPS EASYVISION WORKSTATION:

K990335 is an FDA 510(k) clearance for PHILIPS EASYVISION WORKSTATION:, manufactured by Philips Medical Systems North America, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K990335 · Philips Medical Systems North America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
218d
Days
Class 2
Risk

K990335 is an FDA 510(k) clearance for the PHILIPS EASYVISION WORKSTATION:. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 218 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 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. Standard predicate reliance. 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 Philips Medical Systems North America, Inc. devices

FDA 510(k) Submission Details - K990335

510(k) Number K990335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1999
Decision Date September 09, 1999
Days to Decision 218 days
Submission Type Traditional
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
111d slower than avg
Panel avg: 107d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 977
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K990335.
VIRGO MRI SYSTEM
K990153 · Millennium Technology Services · Oct 1999
PREFERENCE TREATMENT SYSTEM
K983793 · Northwest Medical Physics Equipment, Inc. · Oct 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
K992892 · Magnetic Moments, LLC · Sep 1999
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
K992135 · Ge Medical Systems, Inc. · Sep 1999
QUANTITATIVE FLOW
K992225 · Philips Medical Systems (Cleveland), Inc. · Sep 1999
MRGP OPTICAL TRACKING UNIT
K991943 · Philips Medical Systems (Cleveland), Inc. · Aug 1999