The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Pinnacle3 Smartarc.
| Device ID | K090808 |
| 510k Number | K090808 |
| Device Name: | PINNACLE3 SMARTARC |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 5520 NOBEL DR. SUITE 125 Fitchburg, WI 53711 |
| Contact | Jill Kaeder |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-04-03 |
| Summary: | summary |