The following data is part of a premarket notification filed by Radiomed Corp. with the FDA for Radiomed Source.
| Device ID | K001070 |
| 510k Number | K001070 |
| Device Name: | RADIOMED SOURCE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | RADIOMED CORP. 9 LINNELL CIRCLE Billerica, MA 01821 |
| Contact | John Schwamb |
| Correspondent | John Schwamb RADIOMED CORP. 9 LINNELL CIRCLE Billerica, MA 01821 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-03 |
| Decision Date | 2000-10-24 |