The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Pinnacle3 Radiation Therapy Planning System.
| Device ID | K130992 |
| 510k Number | K130992 |
| Device Name: | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 816 CONGRESS AVE, SUITE 1400 Austin, TX 78701 |
| Contact | Diane Sudduth |
| Correspondent | Diane Sudduth PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 816 CONGRESS AVE, SUITE 1400 Austin, TX 78701 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-10 |
| Decision Date | 2013-06-14 |
| Summary: | summary |