The following data is part of a premarket notification filed by Isodose Control B.v. with the FDA for Flexiplan 3d And 3d+.
| Device ID | K091145 |
| 510k Number | K091145 |
| Device Name: | FLEXIPLAN 3D AND 3D+ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ISODOSE CONTROL B.V. MAXWELLSTRAAT 16 Ede, NL 6716 Bx |
| Contact | Hub Van De Bergh |
| Correspondent | Hub Van De Bergh ISODOSE CONTROL B.V. MAXWELLSTRAAT 16 Ede, NL 6716 Bx |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-05-27 |
| Summary: | summary |