The following data is part of a premarket notification filed by Intramedical Imaging, Llc with the FDA for Lesion-loc Iodine I-125 Seed/needle.
| Device ID | K142668 |
| 510k Number | K142668 |
| Device Name: | Lesion-Loc Iodine I-125 Seed/Needle |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | Intramedical Imaging, LLC 12569 Crenshaw Blvd. Hawthorne, CA 90250 |
| Contact | Farhad Daghighian |
| Correspondent | Farhad Daghighian Intramedical Imaging, LLC 12569 Crenshaw Blvd. Hawthorne, CA 90250 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2014-11-21 |
| Summary: | summary |