The following data is part of a premarket notification filed by Canberra Industries, Inc. with the FDA for Imageview 46000.
Device ID | K925265 |
510k Number | K925265 |
Device Name: | IMAGEVIEW 46000 |
Classification | Camera, Multi Format, Radiological |
Applicant | CANBERRA INDUSTRIES, INC. 150 SPRING LAKE DR. Itasca, IL 60143 |
Contact | Johannes Smits |
Correspondent | Johannes Smits CANBERRA INDUSTRIES, INC. 150 SPRING LAKE DR. Itasca, IL 60143 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-19 |
Decision Date | 1993-06-09 |