The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Extend Frame System, Model 1009633.
| Device ID | K092083 |
| 510k Number | K092083 |
| Device Name: | EXTEND FRAME SYSTEM, MODEL 1009633 |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
| Contact | Abders Skoglund |
| Correspondent | Abders Skoglund ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-09 |
| Decision Date | 2009-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340048307994 | K092083 | 000 |
| 07340048305464 | K092083 | 000 |
| 07340048305433 | K092083 | 000 |
| 07340048305419 | K092083 | 000 |
| 07340048305396 | K092083 | 000 |
| 07340048305372 | K092083 | 000 |
| 07340048305341 | K092083 | 000 |
| 07340048304597 | K092083 | 000 |
| 07340048305051 | K092083 | 000 |
| 07340048304603 | K092083 | 000 |
| 07340048305495 | K092083 | 000 |
| 07340048305525 | K092083 | 000 |
| 07340048305556 | K092083 | 000 |
| 07340048307970 | K092083 | 000 |
| 07340048306782 | K092083 | 000 |
| 07340048306775 | K092083 | 000 |
| 07340048306768 | K092083 | 000 |
| 07340048306744 | K092083 | 000 |
| 07340048306737 | K092083 | 000 |
| 07340048306720 | K092083 | 000 |
| 07340048306713 | K092083 | 000 |
| 07340048306706 | K092083 | 000 |
| 07340048304580 | K092083 | 000 |