The following data is part of a De Novo classification by Radiadyne with the FDA for Prostate Immobilizer Rectal Balloon.
| DeNovo ID | DEN130036 |
| Device Name: | PROSTATE IMMOBILIZER RECTAL BALLOON |
| Classification | Prostate Immobilizer Rectal Balloon |
| Applicant | RADIADYNE 901 New York Avenue, Nw Washington, DC 20001 |
| Contact | Mark A Heller |
| Product Code | PCT |
| CFR Regulation Number | 892.5720 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K132194 |
| Review Advisory Board | Radiology |
| Classification Advisory | Radiology |
| Type | Direct |
| Date Received | 2013-07-15 |
| Decision Date | 2014-01-28 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20851546007213 | DEN130036 | 000 |
| 20851546007107 | DEN130036 | 000 |
| 00851546007092 | DEN130036 | 000 |
| 20851546007053 | DEN130036 | 000 |
| 20851546007046 | DEN130036 | 000 |
| 20851546007039 | DEN130036 | 000 |
| 20851546007022 | DEN130036 | 000 |
| 20851546007015 | DEN130036 | 000 |
| 20851546007091 | DEN130036 | 000 |