The following data is part of a premarket notification filed by Elscint Mr, Inc. with the FDA for Esteem 1.5t Mri System.
| Device ID | K962677 |
| 510k Number | K962677 |
| Device Name: | ESTEEM 1.5T MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ELSCINT MR, INC. 2555 MIDPOINT DR. Fort Collins, CO 80525 |
| Contact | Elizabeth F Lowder |
| Correspondent | Elizabeth F Lowder ELSCINT MR, INC. 2555 MIDPOINT DR. Fort Collins, CO 80525 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-09 |
| Decision Date | 1996-09-20 |
| Summary: | summary |