The following data is part of a premarket notification filed by Radiomed Corp. with the FDA for Radiomed Soft Tissue Marker.
| Device ID | K031206 |
| 510k Number | K031206 |
| Device Name: | RADIOMED SOFT TISSUE MARKER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | RADIOMED CORP. ONE INDUSTRIAL WAY Tyngsboro, MA 01879 |
| Contact | Gordon Roberts |
| Correspondent | Gordon Roberts RADIOMED CORP. ONE INDUSTRIAL WAY Tyngsboro, MA 01879 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-16 |
| Decision Date | 2003-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B887FP00090 | K031206 | 000 |
| B887FP00580 | K031206 | 000 |
| B887FP00590 | K031206 | 000 |
| B887FP035050 | K031206 | 000 |
| B887FP050050 | K031206 | 000 |
| B887FP050100 | K031206 | 000 |
| B887FP050200 | K031206 | 000 |
| B887FP050300 | K031206 | 000 |
| B887FP07550 | K031206 | 000 |
| B887FP00570 | K031206 | 000 |
| B887FP00200 | K031206 | 000 |
| B887FP00190 | K031206 | 000 |
| B887FP00110 | K031206 | 000 |
| B887FP00120 | K031206 | 000 |
| B887FP00130 | K031206 | 000 |
| B887FP00140 | K031206 | 000 |
| B887FP00150 | K031206 | 000 |
| B887FP00160 | K031206 | 000 |
| B887FP00170 | K031206 | 000 |
| B887FP00180 | K031206 | 000 |
| B887FP110050 | K031206 | 000 |
| EIBAFP00090 | K031206 | 000 |
| EIBAFP00580 | K031206 | 000 |
| EIBAFP00590 | K031206 | 000 |
| EIBAFP035050 | K031206 | 000 |
| EIBAFP050050 | K031206 | 000 |
| EIBAFP050100 | K031206 | 000 |
| EIBAFP050200 | K031206 | 000 |
| EIBAFP050300 | K031206 | 000 |
| EIBAFP07550 | K031206 | 000 |
| EIBAFP00570 | K031206 | 000 |
| EIBAFP00200 | K031206 | 000 |
| EIBAFP00190 | K031206 | 000 |
| EIBAFP00110 | K031206 | 000 |
| EIBAFP00120 | K031206 | 000 |
| EIBAFP00130 | K031206 | 000 |
| EIBAFP00140 | K031206 | 000 |
| EIBAFP00150 | K031206 | 000 |
| EIBAFP00160 | K031206 | 000 |
| EIBAFP00170 | K031206 | 000 |
| EIBAFP00180 | K031206 | 000 |
| EIBAFP110050 | K031206 | 000 |