K113259 is an FDA 510(k) clearance for the NOTOUCH BREASTSCAN. This device is classified as a System, Telethermographic (adjunctive Use) (Class I - General Controls, product code LHQ).
Submitted by Ue Lifesciences, Inc. (Chester Springs, US). The FDA issued a Cleared decision on February 10, 2012, 98 days after receiving the submission on November 4, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K113259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2011 |
| Decision Date | February 10, 2012 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHQ - System, Telethermographic (adjunctive Use) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.2980 |