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Phone: (940) 440-9791

Fax: (940) 580-2665

Email: sales@otechimg.com

Address:
215 E University Dr, Suite B
Denton, TX 76209-2011
USA

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OTech Cares

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Individual Training

Face-to-Face Seminars (Dallas)

Fundamentals of Clinical & IT (PARCA CPAS) PACS System Administration (PARCA CPSA) Comprehensive DICOM Certification
(PARCA CDIP) Comprehensive HL7: V2 and FHIR

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Scholarships

On-line Classes (Instructer-led)

PACS Core Essentials DICOM Core Essentials DICOM Certification Bootcamp HL7 v2 Core Essentials HL7 FHIR Core Essentials IHE/XDS Core Essentials

Self Study (At Your Own Pace)

PACS Clinical (PARCA CPAS-CLIN) PACS IT (PARCA CPAS-IT) PACS Administration Comprehensive DICOM (PARCA CDIP) Comprehensive HL7

List of All Self Study Courses

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Corporate Training

Face-to-Face Seminars (Dallas)

Fundamentals of Clinical & IT (PARCA CPAS) PACS System Administration (PARCA CPSA) Comprehensive DICOM Certification
(PARCA CDIP) Comprehensive HL7: V2 and FHIR Advanced DICOM, HL7 and IHE Advanced PACS, DICOM, HL7 Troubleshooting PACS Certification and Advanced Training VNA Implementation

Corporate training details and pricing.

On-line Classes (Instructer-led)

PACS Core Essentials DICOM Core Essentials DICOM Certification Bootcamp HL7 v2 Core Essentials HL7 FHIR Core Essentials IHE/XDS Core Essentials

Corporate training details and pricing.

Self Study (At Your Own Pace)

PACS Clinical (PARCA CPAS-CLIN) PACS IT (PARCA CPAS-IT) PACS Administration Comprehensive DICOM (PARCA CDIP) Comprehensive HL7

List of All Self Study Courses

Corporate training details and pricing.
Academic Training

Self Study (At Your Own Pace)

PACS Clinical (PARCA CPAS-CLIN) PACS IT (PARCA CPAS-IT) PACS Administration Comprehensive DICOM (PARCA CDIP) Comprehensive HL7

List of All Self Study Courses

Corporate/Academic licensing training
details and pricing.
Certification

OTech Certification & Accreditation

PACS Certification

CPAS CPSA CIIP

Standards Certification

CDIP HL7

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Books

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Textbooks & eBooks

PACS Fundamentals DICOM Basics HL7 Messaging DICOM/HL7 Reference Guide

Packages

PACS, DICOM, HL7 and Guide 4 Book Package

Study Guides

Clinical Associate (CPAS-CLIN) IT Associate (CPAS-IT) System Administrator (CPSA) Imaging and Informatics (CIIP) DICOM Integration (CDIP) HL7 HL7 FHIR

By Category

PACS DICOM HL7

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Tools

Software

HL7 Simulator (OT-SEND) DICOM Modality Simulator (OT-DICE)

Software Packages

Hospital Simulator

By Category

PACS DICOM HL7

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Modality Simulator

OT-DICE is an active DICOM test tool which is very simple to set up and operate, even with no special training.
Consulting

PACS Regulatory FDA Consulting

PACS 510(k) Filing FDA and Quality Audit Quality System Implementation

Healthcare Imaging and IT Consulting

PACS/RIS Consulting Connectivity Security (HIPAA and Cyber security)

Healthcare Imaging and IT Legal Consulting

Expert Witness for Legal Cases

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Let our experts help get you up and running quicker and easier than trying to navigate the entire healthcare IT field by yourself.
Resources

OTech Resources

Blog Facebook Linked In RSS Feed Twitter YouTube OTpedia

Industry Resources

DICOM HL7 PARCA

OTech Blog / Newsletter

OTech Training

OTech provides training and consulting primarily in the area of Medical Imaging and compliance.

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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:

Determine what classification your device falls under so that the appropriate rules for filing etc. can be applied.
Prepare and Submit All Regulatory Filings - 510(k) documentation, Site Registration, and Device Listing.

A typical scenario for filing is as follows:

We determine the device classification based on the product features and specifications as provided by the manufacturer. Only Class II devices require a 510(k) filing. Note that it is not always perfectly clear what classification a device belongs with, there are some "grey area's" and in some cases it is determined by way precedence, i.e. if another manufacturer has gotten a clearance for a certain product in the past, it is very likely that this is required for the vendor's product. In case of doubt, we would consult with the FDA to ask their opinion. Assuming there is no question, this takes a few days at the most, if we have to consult with the FDA it might take a few weeks.
Assuming it is Class 2, we provide the client with a checklist that contains all the documentation that is required, indicating what is the responsibility of the client, and what will be provided by OTech. This includes items such as product specifications, test plans, user documentation (client) as well as hazard analysis, indications of use statement (consultant).
The client indicates what documentation is available. These documents are sent to our consultants and reviewed. Conference calls and e-mails are frequent. If there is documentation missing or incomplete, we will provide examples and templates that can be used by client as basis for their processes to be implemented and accompanying documentation. This process can take from as short as one month, if the organization is committed and dedicated to the process to up to a year. In our experience,, the average time for an organization to make the necessary changes and generate proper documentation seems to be about three to four months.
After we received all the information, it takes us two solid weeks to put the package together and we send in the paperwork.
The FDA will review the submitted paperwork, which takes less than 90 days. Our recent turn-around time for this period has been about 70 days.

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