510(k) K883756

TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM by Toshiba Medical Systems — Product Code LNH

K883756 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems for the device "TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 14, 1988. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Toshiba Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1988
Date Received
September 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type