<--- Back to Details
First PageDocument Content
Health informatics / Food law / Medical physics / Radiology / Medical imaging / Computer-aided diagnosis / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Magnetic resonance imaging / Medicine / Health / Food and Drug Administration
Health informatics
Food law
Medical physics
Radiology
Medical imaging
Computer-aided diagnosis
Center for Devices and Radiological Health
Federal Food
Drug
and Cosmetic Act
Magnetic resonance imaging
Medicine
Health
Food and Drug Administration

Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions

Add to Reading List

Source URL: www.fda.gov

Download Document from Source Website

File Size: 164,54 KB

Share Document on Facebook

Similar Documents

NEWS  The Cosmetics Industry OVERVIEW In the United States cosmetics are officially regulated by the Food & Drug Administration as a result of the Food, Drug and Cosmetic Act passed inThere is also a self-regulato

NEWS The Cosmetics Industry OVERVIEW In the United States cosmetics are officially regulated by the Food & Drug Administration as a result of the Food, Drug and Cosmetic Act passed inThere is also a self-regulato

DocID: 1uASt - View Document

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

DocID: 1tBOU - View Document

RETAIL COMPLIANCE CHECK INSPECTIONS AND FDA ACTIONS: AN OVERVIEW FOR TOBACCO RETAILERS Presented by Michelle Jackson

RETAIL COMPLIANCE CHECK INSPECTIONS AND FDA ACTIONS: AN OVERVIEW FOR TOBACCO RETAILERS Presented by Michelle Jackson

DocID: 1roDS - View Document

Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration

Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration

DocID: 1rmMY - View Document

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff

DocID: 1r7Xt - View Document