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 |