K922287 is an FDA 510(k) clearance for the E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS. This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).
Submitted by I.Z.I. Corp. (Owings Mills, US). The FDA issued a Cleared decision on October 16, 1992, 154 days after receiving the submission on May 15, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.
| 510(k) Number | K922287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 1992 |
| Decision Date | October 16, 1992 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPQ — System, Simulation, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5840 |