The following data is part of a premarket notification filed by Ptw-new York Corp. with the FDA for Ptw David Imrt Qc Verification System.
| Device ID | K062817 |
| 510k Number | K062817 |
| Device Name: | PTW DAVID IMRT QC VERIFICATION SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | PTW-NEW YORK CORP. 205 PARK AVE. Hicksville, NY 11801 |
| Contact | Richard D Barker |
| Correspondent | Richard D Barker PTW-NEW YORK CORP. 205 PARK AVE. Hicksville, NY 11801 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-20 |
| Decision Date | 2006-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPTWT340850 | K062817 | 000 |
| EPTWT340840 | K062817 | 000 |
| EPTWT340790 | K062817 | 000 |
| EPTWT340770 | K062817 | 000 |
| EPTWT340650 | K062817 | 000 |
| EPTWT340640 | K062817 | 000 |
| EPTWT160310 | K062817 | 000 |
| EPTWS0700160 | K062817 | 000 |