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FDA

Stryker Imaging is dedicated to providing the highest quality product standards in the industry to assure maximum customer satisfaction with dependable and reputable performance. The company is an FDA registered medical device establishment. The company is in compliance with GMP 21CFR820 and ISO 9000 standards. A supplier certification program provides assurance that our suppliers adhere to established quality management standards assuring 100% specification compliance.

Stryker Imaging markets OrthoPad, a Medical Image Communications System and a Medical Image Storage System listed with FDA as Regulatory Class I device under 21 CFR 892.2020 and OfficePACS which has FDA 510(k) clearance for marketing in the U.S.A and registered with the FDA as K994228 Regulatory Class II under 21 CFR 892.2050.

DICOM Conformance Statement
Available upon request. Contact Customer Service »

HIPAA
On April 14, 2003 the Privacy Standards of the Health Insurance and Portability Act, HIPAA as defined in 45 CFR Parts 160 and 164 was enacted into law.

Stryker Imaging is committed to helping its customers comply with the HIPAA Regulations as they relate to PHI. We share your commitment to comply with the Privacy Regulations, thus Stryker Imaging software technology has security safeguards to protect the privacy, confidentiality, availability and integrity of the electronic protected health information it receives from its customers.

These safeguards such as access management, retrievable backup procedures, encryption, limited audit controls and automatic logoff, to name a few, exceed the required measures necessary under the Privacy and Security Regulations of HIPAA. Therefore, Stryker Imaging is in a position to help its customers achieve full compliance with those aspects of the Regulation in the services it provides.

ACR
Download the PDF regarding Teleradiology Standards.
Download the PDF regarding Digital Image Data Management Standards.

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