The following data is part of a premarket notification filed by Mr Medical Solutions Llc with the FDA for 1.5 Tesla 16- Channel Receive-only Phased- Array Head Coil For Siemans.
| Device ID | K093689 |
| 510k Number | K093689 |
| Device Name: | 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MR MEDICAL SOLUTIONS LLC 310 VISTA PARK DRIVE Pittsburg, PA 15205 |
| Contact | Fahad Alradady |
| Correspondent | Fahad Alradady MR MEDICAL SOLUTIONS LLC 310 VISTA PARK DRIVE Pittsburg, PA 15205 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-30 |
| Decision Date | 2010-08-31 |
| Summary: | summary |