510(k) K232021
K232021 is an FDA 510(k) premarket notification submitted by Philips Healthcare (Suzhou) Co., Ltd. for the device "Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Philips Healthcare (Suzhou) Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2023
- Date Received
- July 7, 2023
- Clearance Type
- Traditional
- 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