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 more than 100 filings (see attached list) for several companies, each successfully completed, 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

APR 17
Module 2: DICOM Communication Services and SR

APR 18
Module 3: Image quality, DICOM Web and Troubleshooting

APR 19
Module 4: Compression, Media, Conformance

MAY 14-16
Comprehensive DICOM Certification

MAY 17-18
Comprehensive HL7: V2 and FHIR

MAY 21-22
Fundamentals of Clinical and IT (PARCA CPAS)


Click here to view entire training schedule.

Tips & Tricks

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

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