The following data is part of a premarket notification filed by Isodose Control B.v. with the FDA for Flexiplan Brachytherapy Treatment Planning System.
| Device ID | K081112 |
| 510k Number | K081112 |
| Device Name: | FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ISODOSE CONTROL B.V. LANDJUWEEL 11 Veenendaal, NL 3905 Pe |
| Contact | Hub Van De Bergh |
| Correspondent | Hub Van De Bergh ISODOSE CONTROL B.V. LANDJUWEEL 11 Veenendaal, NL 3905 Pe |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-18 |
| Decision Date | 2008-07-29 |
| Summary: | summary |