The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Vienna System.
| Device ID | K142597 |
| 510k Number | K142597 |
| Device Name: | Vienna System |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Contact | Chuck Smith |
| Correspondent | Chuck Smith MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2015-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817330021717 | K142597 | 000 |
| 00817330020369 | K142597 | 000 |
| 00817330020352 | K142597 | 000 |
| 00817330020345 | K142597 | 000 |
| 00817330020321 | K142597 | 000 |
| 00817330020314 | K142597 | 000 |
| 00817330020307 | K142597 | 000 |
| 00817330020291 | K142597 | 000 |
| 00817330020284 | K142597 | 000 |
| 00817330020277 | K142597 | 000 |
| 00817330020260 | K142597 | 000 |
| 00817330020246 | K142597 | 000 |
| 00817330020239 | K142597 | 000 |
| 00817330020222 | K142597 | 000 |
| 00817330020215 | K142597 | 000 |
| 00817330020208 | K142597 | 000 |
| 00817330020376 | K142597 | 000 |
| 00817330020383 | K142597 | 000 |
| 00817330021700 | K142597 | 000 |
| 00817330021694 | K142597 | 000 |
| 00817330021687 | K142597 | 000 |
| 00817330021670 | K142597 | 000 |
| 00817330021663 | K142597 | 000 |
| 00817330021656 | K142597 | 000 |
| 00817330021649 | K142597 | 000 |
| 00817330021632 | K142597 | 000 |
| 00817330021625 | K142597 | 000 |
| 00817330021618 | K142597 | 000 |
| 00817330021601 | K142597 | 000 |
| 00817330020420 | K142597 | 000 |
| 00817330020413 | K142597 | 000 |
| 00817330020406 | K142597 | 000 |
| 00817330020390 | K142597 | 000 |
| 00817330020192 | K142597 | 000 |