The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Dynacad/prostate Interventional (dynaloc/prostate).
| Device ID | K133030 |
| 510k Number | K133030 |
| Device Name: | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) |
| Classification | System, Image Processing, Radiological |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville, FL 32608 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville, FL 32608 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2014-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838082885 | K133030 | 000 |