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U.S. Department of Health and Human Services

Product Classification

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Device transducer, ultrasonic, diagnostic
Regulation Description Diagnostic ultrasonic transducer.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeITX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1570
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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