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 | K143254 |
| 510k Number | K143254 |
| 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 | Nancy Burke |
| 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 | 2014-11-13 |
| Decision Date | 2014-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869063287 | K143254 | 000 |
| 04056869003511 | K143254 | 000 |
| 04056869235417 | K143254 | 000 |