Ultrasound, Sinus

Product Code: LWI

Radiology Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1560


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as LWI

1657Ultrasound, Sinus

Total Product Life Cycle (TPLC) Devices

1657Ultrasound, Sinus

Pre-market Notifications for LWI

K960421SINUSCAN 102/SINUSPRINTFERGUSON MEDICAL
K960044ULTRAMAX/MODEL NUMBER A1ENTLAB OY
K874081ENTERSCANPIE DATA MEDICAL BV

Maude Adverse Events

REF THREE HOLE SHELL 56MMSMITH & NEPHEW, INC.2018-06-01

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