510(k) K113259
K113259 is an FDA 510(k) premarket notification submitted by Ue Lifesciences, Inc. for the device "NOTOUCH BREASTSCAN". The FDA issued a decision of Substantially Equivalent on February 10, 2012. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Ue Lifesciences, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2012
- Date Received
- November 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Telethermographic (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type