PACS 510(k) Filing

Medical devices, especially those from PACS vendors, often classify as "Class II" which means that filing with the FDA is required prior to selling your product in the US. OTech is an independent agency and specializes in filings for PACS and related devices. We have done many filings (see attached list) for several companies, both from within as well as outside the US, and always been able to achieve the filing approval within the allotted timeframe. We help you with this process through:


A typical scenario for filing is as follows:

Request Information

Specials

CIIP Study Guide - $135
HL7 Study Guide - $119
PACS Clinical Package - $595
PACS IT Package - $595

Training Schedule

JUN 14
VNA Implementation Requirements and Lessons Learned

JUN 19-21
Comprehensive DICOM

JUN 22-23
Comprehensive HL7 (V2)

JUN 28-JUL 1
PACS System Administration

AUG 14
PACS Core Essentials

AUG 15
DICOM Core Essentials


Click here to view entire training schedule.

Tips & Tricks

Click here to view the latest video regarding the DICOM sniffer.
DICOM Video

Stay Connected

View Our BlogVisit Us On FacebookKeep In Touch On Linked InSubscribe To Our RSS FeedFollow Us On TwitterSubscribe To Our YouTube ChannelHangout on Google+
© 2017 OTech, Inc. All rights reserved.