K232762
- 510(k) number
- K232762
- Device name
- dS Breast Coil 7ch 1.5T
- Applicant
- Invivo Corporation (Business Trade Name: Philips) FL · US
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2023-10-03
- Date received
- 2023-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232762.pdf
Official FDA record: K232762
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.