The following data is part of a premarket notification filed by Alltech Medical Systems America, Inc. with the FDA for Alltech Echostar 1.5 T Mr System.
| Device ID | K082100 |
| 510k Number | K082100 |
| Device Name: | ALLTECH ECHOSTAR 1.5 T MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ALLTECH MEDICAL SYSTEMS AMERICA, INC. 30825 AURORA ROAD SUITE 100 Solon, OH 44139 |
| Contact | John Duraj |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-25 |
| Decision Date | 2008-08-06 |