The following data is part of a premarket notification filed by Iba Dosimetry Gmbh with the FDA for Omnipro Incline.
| Device ID | K092018 |
| 510k Number | K092018 |
| Device Name: | OMNIPRO INCLINE |
| Classification | Accelerator, Linear, Medical |
| Applicant | IBA DOSIMETRY GMBH 3150 STAGE POST DR SUITE 110 Bartlett, TN 38133 |
| Contact | Chuck Lindley |
| Correspondent | Chuck Lindley IBA DOSIMETRY GMBH 3150 STAGE POST DR SUITE 110 Bartlett, TN 38133 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EIBAE60000101 | K092018 | 000 |
| EIBAE60000001 | K092018 | 000 |
| EIBAE3055005V0010 | K092018 | 000 |
| EIBAE3055000V0010 | K092018 | 000 |