The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Elekta Oncology Systems Precise Treatment Table.
Device ID | K983678 |
510k Number | K983678 |
Device Name: | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE |
Classification | Couch, Radiation Therapy, Powered |
Applicant | ELEKTA INSTRUMENTS, INC. 3155 NORTHWOODS PKWY. N.W. Norcross, GA 30071 |
Contact | Paul L Sumner |
Correspondent | Paul L Sumner ELEKTA INSTRUMENTS, INC. 3155 NORTHWOODS PKWY. N.W. Norcross, GA 30071 |
Product Code | JAI |
CFR Regulation Number | 892.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-20 |
Decision Date | 1999-01-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060191071086 | K983678 | 000 |