The following data is part of a premarket notification filed by Sensus Healthcare with the FDA for Sensus Helthcare Image-duided Superficial Radiotherapy System.
| Device ID | K131582 |
| 510k Number | K131582 |
| Device Name: | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM |
| Classification | System, Therapeutic, X-ray |
| Applicant | SENSUS HEALTHCARE 851 BROKEN SOUND PKWY NW #215 Boca Raton, FL 33487 |
| Contact | Kal Fishman |
| Correspondent | Kal Fishman SENSUS HEALTHCARE 851 BROKEN SOUND PKWY NW #215 Boca Raton, FL 33487 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-08-28 |
| Summary: | summary |