510(k) K173507
K173507 is an FDA 510(k) premarket notification submitted by Philips Healthcare (Suzhou) Co., Ltd. for the device "Prodiva 1.5T CX and Prodiva 1.5T CS R5.4". The FDA issued a decision of Substantially Equivalent on June 15, 2018. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), 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
- June 15, 2018
- Date Received
- November 13, 2017
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type