Cleared Special

K011485 - PINNACLE MAGNETIC RESONANCE IMAGING SCANNER

K011485 is an FDA 510(k) clearance for PINNACLE MAGNETIC RESONANCE IMAGING SCANNER, manufactured by Fonar Corp.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 22-day FDA review.

K011485 · Fonar Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
22d
Days
Class 2
Risk

K011485 is an FDA 510(k) clearance for the PINNACLE MAGNETIC RESONANCE IMAGING SCANNER. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Fonar Corp. (Melville, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011485

510(k) Number K011485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2001
Decision Date June 06, 2001
Days to Decision 22 days
Submission Type Special
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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 1107
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K011485.
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · GE Medical Systems · Aug 2001
INFINION ENHANCEMENT PACKAGE
K011296 · Philips Medical Systems (Cleveland), Inc. · Jul 2001
QED DIODE DETECTORS, MODELS 1112-1116
K011466 · Sun Nuclear Corp. · Jun 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · Siemens Medical Solutions USA, Inc. · May 2001
ULTRAGUIDE MR-GUIDE 3000
K011418 · Ultraguide , Ltd. · May 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · Philips Medical Systems (Cleveland), Inc. · May 2001
K011485 · PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
Download PDF FDA Summary Fonar Corp.