The following data is part of a premarket notification filed by Innovative Magnetic Resonance Imaging Systems Inc. with the FDA for Neuro Ii-s.
| Device ID | K050132 |
| 510k Number | K050132 |
| Device Name: | NEURO II-S |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Contact | Thomas M Tsakeris |
| Correspondent | Thomas M Tsakeris INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-21 |
| Decision Date | 2005-02-15 |
| Summary: | summary |