The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Pinnacle3 Radiation Therapy Planning System.
| Device ID | K041577 |
| 510k Number | K041577 |
| Device Name: | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ADAC LABORATORIES 6400 ENTERPRISE LANE,STE.201 Madison, WI 53719 |
| Contact | Randy Vader |
| Correspondent | William J Sammons UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-06-25 |
| Summary: | summary |