The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Esie Apps Suite.
| Device ID | K132062 |
| 510k Number | K132062 |
| Device Name: | ESIE APPS SUITE |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Patrick J Lynch |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2013-07-23 |
| Summary: | summary |