The following data is part of a premarket notification filed by Medi-physics, Inc. with the FDA for Rapid Strand Rx.
| Device ID | K122764 |
| 510k Number | K122764 |
| Device Name: | RAPID STRAND RX |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | MEDI-PHYSICS, INC. 3350 NORTH RIDGE AVE. Arlington Heights, IL 60004 |
| Contact | David Risley |
| Correspondent | David Risley MEDI-PHYSICS, INC. 3350 NORTH RIDGE AVE. Arlington Heights, IL 60004 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-10 |
| Decision Date | 2012-12-28 |
| Summary: | summary |