The following data is part of a premarket notification filed by Massachusetts General Hospital with the FDA for Northeast Proton Therapy Center.
| Device ID | K983332 |
| 510k Number | K983332 |
| Device Name: | NORTHEAST PROTON THERAPY CENTER |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | MASSACHUSETTS GENERAL HOSPITAL 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MASSACHUSETTS GENERAL HOSPITAL 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-22 |
| Decision Date | 2001-07-20 |
| Summary: | summary |