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U.S. Department of Health and Human Services

Product Classification

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Device system, imaging, pulsed doppler, ultrasonic
Regulation Description Ultrasonic pulsed doppler imaging system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIYN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
Third Party Review
Accredited Persons

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