The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Webrad Computed Radiography Quality Assurance Workstation.
Device ID | K991626 |
510k Number | K991626 |
Device Name: | WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Contact | Garet Van Gennep |
Correspondent | Garet Van Gennep ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-11 |
Decision Date | 1999-07-02 |