510(k) K040640

MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL by Igc-Medical Advances, Inc. — Product Code MOS

K040640 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL". The FDA issued a decision of Substantially Equivalent on Mar 22, 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
Mar 22, 2004
Date Received
Mar 10, 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 K040640. Report a data issue: hello@regdatalab.com.