K101166 is an FDA 510(k) clearance for the 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on October 7, 2010, 164 days after receiving the submission on April 26, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K101166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2010 |
| Decision Date | October 07, 2010 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |