The following data is part of a premarket notification filed by Siemens Medical Corp. with the FDA for Numaris 4va15a.
| Device ID | K012202 |
| 510k Number | K012202 |
| Device Name: | NUMARIS 4VA15A |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Contact | Jamie Yieh |
| Correspondent | Jamie Yieh SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-09-27 |
| Summary: | summary |