The following data is part of a premarket notification filed by Loma Linda University Medical Center with the FDA for Loma Linda Univ. Proton Beam Therapy System.
| Device ID | K872369 |
| 510k Number | K872369 |
| Device Name: | LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM |
| Classification | Synchrotron, Medical |
| Applicant | LOMA LINDA UNIVERSITY MEDICAL CENTER 11234 ANDERSON ST. P.O. BOX 2000 Loma Linda, CA 92354 |
| Contact | J Anderson |
| Correspondent | J Anderson LOMA LINDA UNIVERSITY MEDICAL CENTER 11234 ANDERSON ST. P.O. BOX 2000 Loma Linda, CA 92354 |
| Product Code | IWM |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-19 |
| Decision Date | 1988-02-22 |