510(k) K243033

dS Wrist coil 8ch 1.5T by Philips Medical Systems Nederland B.V. — Product Code MOS

K243033 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "dS Wrist coil 8ch 1.5T". The FDA issued a decision of Substantially Equivalent on October 18, 2024. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Philips Medical Systems Nederland B.V. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2024
Date Received
September 27, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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