The following data is part of a premarket notification filed by Ue Lifesciences, Inc. with the FDA for Notouch Breastscan.
| Device ID | K113259 |
| 510k Number | K113259 |
| Device Name: | NOTOUCH BREASTSCAN |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | UE LIFESCIENCES, INC. 4435 LOBELLA COURT Chester Springs, PA 19425 |
| Contact | Mihir Shah |
| Correspondent | Mihir Shah UE LIFESCIENCES, INC. 4435 LOBELLA COURT Chester Springs, PA 19425 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-04 |
| Decision Date | 2012-02-10 |
| Summary: | summary |