The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Xio Rtp System.
Device ID | K102216 |
510k Number | K102216 |
Device Name: | XIO RTP SYSTEM |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 13723 RIVERPORT DR SUITE 100 Maryland Heights, MO 63043 |
Contact | Kathryn Stinson |
Correspondent | Kathryn Stinson COMPUTERIZED MEDICAL SYSTEMS, INC. 13723 RIVERPORT DR SUITE 100 Maryland Heights, MO 63043 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-06 |
Decision Date | 2010-10-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858164002114 | K102216 | 000 |