The following data is part of a premarket notification filed by Alltech Medical Systems America, Inc. with the FDA for Echostar Spica 1.5t Mr System.
| Device ID | K113511 |
| 510k Number | K113511 |
| Device Name: | ECHOSTAR SPICA 1.5T MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ALLTECH MEDICAL SYSTEMS AMERICA, INC. 6551 COCHRAN ROAD Solon, OH 44139 |
| Contact | Michaeleen Dom |
| Correspondent | Michaeleen Dom ALLTECH MEDICAL SYSTEMS AMERICA, INC. 6551 COCHRAN ROAD Solon, OH 44139 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-28 |
| Decision Date | 2012-05-02 |
| Summary: | summary |