The following data is part of a premarket notification filed by Icrco Inc. with the FDA for Icrco Clarity Viewer.
Device ID | K132499 |
510k Number | K132499 |
Device Name: | ICRCO CLARITY VIEWER |
Classification | System, Image Processing, Radiological |
Applicant | ICRCO INC. 2580 WEST 237TH STREET Torrance, CA 90505 |
Contact | Greg Wachtler |
Correspondent | Greg Wachtler ICRCO INC. 2580 WEST 237TH STREET Torrance, CA 90505 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-09 |
Decision Date | 2014-01-21 |