The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Integradweb Pacs System.
Device ID | K072986 |
510k Number | K072986 |
Device Name: | INTEGRADWEB PACS SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | GE HEALTHCARE 25 WALNUT STREET Monroe, CT 06468 |
Contact | Jillian M Reed |
Correspondent | Jillian M Reed GE HEALTHCARE 25 WALNUT STREET Monroe, CT 06468 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-23 |
Decision Date | 2007-11-20 |