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:

PACS Regulatory FDA Consulting (Per Hour)

Price: $ 300.00   Add to Cart

Request Information

Specials

CIIP Study Guide - $135
HL7 Study Guide - $115
PACS Clinical Package - $595
PACS IT Package - $595

Training Schedule

NOV 4-5
Fundamentals of Clinical and IT (PARCA CPAS)

NOV 6-9
PACS System Administration

NOV 11-12
Comprehensive HL7: V2 and FHIR

NOV 13-15
Comprehensive DICOM Certification

FEB 10
PACS On-line Core Essentials

FEB 11
HL7 v2 On-line Core Essentials


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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