Cleared Special

K093984 - PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01

K093984 is an FDA 510(k) clearance for PICA WHOLE BODY MRI SYSTEM MODEL TMS-MR..., manufactured by Time Medical Limited. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 90-day FDA review.

K093984 · Time Medical Limited · Radiology device
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Mar 2010
Decision
90d
Days
Class 2
Risk

K093984 is an FDA 510(k) clearance for the PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Time Medical Limited (Shanghai, CN). The FDA issued a Cleared decision on March 24, 2010 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Time Medical Limited devices

FDA 510(k) Submission Details - K093984

510(k) Number K093984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2009
Decision Date March 24, 2010
Days to Decision 90 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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.

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