510(k) K041185

TORSO ARRAY COIL, MODEL 558GE-64 by Igc-Medical Advances, Inc. — Product Code MOS

K041185 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "TORSO ARRAY COIL, MODEL 558GE-64". The FDA issued a decision of Substantially Equivalent on May 14, 2004. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Igc-Medical Advances, Inc. has 6 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2004
Date Received
May 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type
510(k)

Source: FDA 510(k) database entry for K041185. Report a data issue: hello@regdatalab.com.