Cleared Traditional

K091444 - PERFSCAPE

K091444 is an FDA 510(k) clearance for PERFSCAPE, manufactured by Olea Medical. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K091444 · Olea Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
66d
Days
Class 2
Risk

K091444 is an FDA 510(k) clearance for the PERFSCAPE. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Olea Medical (Austin, US). The FDA issued a Cleared decision on July 20, 2009 after a review of 66 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 Olea Medical devices

FDA 510(k) Submission Details - K091444

510(k) Number K091444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2009
Decision Date July 20, 2009
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
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 841
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K091444.
O-SCAN MR SYSTEM
K092469 · Esaote, S.P.A. · Dec 2009
NSM-S15 SYSTEM
K092237 · Neusoft Medical Systems Co., Ltd. · Sep 2009
MR-TOUCH OPTION
K083421 · Ge Medical Systems, LLC · Jul 2009
OPTIMA MR450W
K091536 · Ge Medical Systems, LLC · Jul 2009
SYNGO BREVIS
K090038 · Siemens Medical Solutions USA, Inc. · Apr 2009
ECHELON C MRI SYSTEM
K083533 · Hitachi Medical Systems America, Inc. · Feb 2009