K861019 is an FDA 510(k) clearance for the CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD. This device is classified as a Screen, Leaded, Operator Radiation Protector (Class I - General Controls, product code EAK).
Submitted by Phase One Disign Co. (San Rafael, US). The FDA issued a Cleared decision on April 2, 1986, 15 days after receiving the submission on March 18, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K861019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1986 |
| Decision Date | April 02, 1986 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | EAK — Screen, Leaded, Operator Radiation Protector |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |