The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Xrt-7.0.
| Device ID | K964583 |
| 510k Number | K964583 |
| Device Name: | XRT-7.0 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Thomas J Spackman, M.d. F.a.c.r. |
| Correspondent | Thomas J Spackman, M.d. F.a.c.r. ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-01-17 |
| Summary: | summary |