The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.via View&go.
Device ID | K201477 |
510k Number | K201477 |
Device Name: | Syngo.via View&GO |
Classification | System, Image Processing, Radiological |
Applicant | Siemens Healthcare GmbH Siemensstr. 1 Forchheim, DE 91301 |
Contact | Elango Alampalayam Rangappan |
Correspondent | Elango Alampalayam Rangappan Siemens Healthcare GmbH Siemensstr. 1 Forchheim, DE 91301 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-03 |
Decision Date | 2020-07-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869270142 | K201477 | 000 |