K921130 is an FDA 510(k) clearance for the MRX-865. This device is classified as a Assembly, Tube Housing, X-ray, Diagnostic (Class I - General Controls, product code ITY).
Submitted by Mrx-Ray Tube Corp. (Arlington, US). The FDA issued a Cleared decision on September 10, 1992, 184 days after receiving the submission on March 10, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1760.
| 510(k) Number | K921130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1992 |
| Decision Date | September 10, 1992 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | ITY — Assembly, Tube Housing, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1760 |