The following data is part of a premarket notification filed by I.z.i. Corp. with the FDA for Ct/mri Topographic Marker.
| Device ID | K930752 |
| 510k Number | K930752 |
| Device Name: | CT/MRI TOPOGRAPHIC MARKER |
| Classification | System, X-ray, Film Marking, Radiographic |
| Applicant | I.Z.I. CORP. 10 STREAM CT. Owings Mills, MD 21117 |
| Contact | James Zinreich |
| Correspondent | James Zinreich I.Z.I. CORP. 10 STREAM CT. Owings Mills, MD 21117 |
| Product Code | JAC |
| CFR Regulation Number | 892.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1993-11-19 |