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Index of CDRH Web Documents

KEY: Links are numbered according to what type of file they point to. 1=Text, 2=PDF, 3=PowerPoint, 4=Word, 5=XML, 6=See Also. Topics starting with : 0-9  A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z 
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X-Rays
* A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems   [PDF]
* A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use   [PDF]
* A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use [Text] [PDF]
* A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components   [PDF]
* Assessment of the Impact of the Proposed Amendments to the Diagnostic X-ray Equipment Performance Standard addressing Fluoroscopic X-ray Systems (Draft) [Text] [PDF]
* Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)   [PDF]
* Compliance Program for Field Compliance Testing of Cabinet X-Ray Equipment (CP 7386.004); Final Guidance for Industry and FDA Staff [Text] [PDF]
* Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-ray Equipment [Text] [PDF]
* Concepts for Proposed Amendents to the Performance Standard for Diagnostic X-ray Systems [Text]
* Draft Amendments to the Federal Performance Standard for Diagnostic X-ray Systems and their Major Components   [PDF]
* Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components ; Proposed Rule [Text] [PDF]
* Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic X-Ray Equipment [Text] [PDF] [PowerPoint PPT]
* FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers [Text] [PDF]
* FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients [Text]
* Frequently Asked Questions on Cabinet X-ray Systems [Text]
* Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; Final [Text] [PDF]
* Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40   [PDF]
* Guidance on Electronic Products which Emit Radiation [Text]
* Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21-CFR 1002.10   [PDF]
* Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21-CFR 1002.10   [PDF]
* Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21-CFR 1002.10   [PDF]
* Guide for the filing of Annual Reports for X-Ray Components and Systems   [PDF]
* Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems [Text] [PDF]
* Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)   [PDF]
* MRI (Magnetic Resonance Imaging) Safety [Text]
* Nationwide Evaluation of X-ray Trends (NEXT) [Text]
* Proceedings of the ACR/FDA Workshop on Fluoroscopy [Text]
* Recording Information in the Patient's Medical Record that Identifies the Potential for Serious X-Ray Induced Skin Injuries [Text]
* Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems [Text]
* Reviewer Guidance for Automatic X-Ray Film Processor 510(k)   [PDF]
* Undertable X-Ray Source Fluoroscopic and Spot-Film Systems - Test Procedures [Text]
* Whole Body Scanning Using Computed Tomography (CT) [Text]
* X-Ray Record Card   [PDF]
* X-Rays, Pregnancy and You... [Text] [PDF]
* X-Rays: Get The Picture on Protection [Text]
 

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