The following data is part of a premarket notification filed by Radiomed Corporation with the FDA for Radiomed Marker.
| Device ID | K022326 |
| 510k Number | K022326 |
| Device Name: | RADIOMED MARKER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | RADIOMED CORPORATION ONE INDUSTRIAL WAY Tyngsboro, MA 01879 -1400 |
| Contact | Gordon Roberts |
| Correspondent | Gordon Roberts RADIOMED CORPORATION ONE INDUSTRIAL WAY Tyngsboro, MA 01879 -1400 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-18 |
| Decision Date | 2003-01-31 |
| Summary: | summary |