510(k) K232762

dS Breast Coil 7ch 1.5T by Invivo Corporation (Business Trade Name: Philips) — Product Code MOS

K232762 is an FDA 510(k) premarket notification submitted by Invivo Corporation (Business Trade Name: Philips) for the device "dS Breast Coil 7ch 1.5T". The FDA issued a decision of Substantially Equivalent on October 3, 2023. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Invivo Corporation (Business Trade Name: Philips) has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2023
Date Received
September 8, 2023
Clearance Type
Special
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