The following data is part of a premarket notification filed by Siemens Medical Solution, Inc. Usa with the FDA for Somatom Radiation Treatment Planning (rtp) Package.
Device ID | K042229 |
510k Number | K042229 |
Device Name: | SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern, PA 19355 |
Contact | Nealie Hartman |
Correspondent | Nealie Hartman SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern, PA 19355 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-17 |
Decision Date | 2004-09-01 |
Summary: | summary |