The following data is part of a premarket notification filed by Edap Technomed, Inc. with the FDA for Ablatherm Integrated Imaging.
| Device ID | K153023 |
| 510k Number | K153023 |
| Device Name: | Ablatherm Integrated Imaging |
| Classification | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Applicant | EDAP TECHNOMED, INC. 2201 DENTON DR., SUITE 110 Austin, TX 78758 |
| Contact | Marc Oczachowski |
| Correspondent | John C Rewcastle EDAP TECHNOMED, INC. 2201 DENTON DR., SUITE 110 Austin, TX 78758 |
| Product Code | PLP |
| CFR Regulation Number | 876.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-15 |
| Decision Date | 2015-11-06 |
| Summary: | summary |