Medical Grade CD-Rom Disc

Medical Grade Recording Media Is As Important As The Imaging Hardware Itself

The federal government recently issued new regulations for medical image management devices, which include the media used in those devices. And ACS is proud to offer medical grade recording media which meet these regulations, whether it be for medical image storage or a PACS device. Recording media is an essential link in the complete medical imaging chain. The ACS line of multi-modality medical grade recording media is manufactured in strict compliance with CGMP (Current Good Manufacturing Practices), proper medical labeling and reporting procedures. The result is medical grade recording media that helps safeguard the integrity of medical images. To ensure that you are purchasing true medical grade recording media, ask your media vendor if its products comply with the appropriate U.S. Federal regulations:

• 510k for PACS devices (21 CFR Part 807, Subpart E)
• Establishment registration (21 CFR Part 807)
• Device registration (21 CFR Part 807)
• Current good manufacturing practices (21 CFR Part 820)
• Labeling medical devices (21 CFR Part 801 & 21 CFR Part 809)
• Medical Device Reporting (21 CFR Part 803)