The following data is part of a premarket notification filed by Medi-physics, Inc., Dba Ge Healthcare with the FDA for Brachytherapy Source Device, Model 9011.
| Device ID | K081066 |
| 510k Number | K081066 |
| Device Name: | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 |
| Classification | Seed, Isotope, Gold, Titanium, Platinum |
| Applicant | MEDI-PHYSICS, INC., DBA GE HEALTHCARE 101 CARNEGIE CENTRE Princeton, NJ 08540 -6231 |
| Contact | David Risley |
| Correspondent | David Risley MEDI-PHYSICS, INC., DBA GE HEALTHCARE 101 CARNEGIE CENTRE Princeton, NJ 08540 -6231 |
| Product Code | IWG |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-15 |
| Decision Date | 2008-05-05 |
| Summary: | summary |