The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Modified Exel 2400 Elite/u & Exel 2400e/u.
| Device ID | K900170 |
| 510k Number | K900170 |
| Device Name: | MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ELSCINT, INC. 3550 SALT CREEK LN, STE. 105 Arlington Heights, IL 60005 |
| Contact | Rochelle M Sobel |
| Correspondent | Rochelle M Sobel ELSCINT, INC. 3550 SALT CREEK LN, STE. 105 Arlington Heights, IL 60005 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-12 |
| Decision Date | 1990-07-25 |