Submission Details
| 510(k) Number | K071128 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2007 |
| Decision Date | October 10, 2007 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
K071128 is an FDA 510(k) clearance for the SCANSCOPE XT SYSTEM, submitted by Aperio Technologies (Vista, US). The FDA issued a Cleared decision on October 10, 2007, 170 days after receiving the submission on April 23, 2007. This device falls under the Pathology review panel.
| 510(k) Number | K071128 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2007 |
| Decision Date | October 10, 2007 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NOT |
| Device Class | — |