K003736 is an FDA 510(k) clearance for the MRI LINE MARKER. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by I.Z.I. Corp. (Owings Mills, US). The FDA issued a Cleared decision on January 18, 2001, 45 days after receiving the submission on December 4, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K003736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2000 |
| Decision Date | January 18, 2001 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |