CIV-Clear cover

510(k) Number

K211270 ↗

FDA product code

ITX

Device class

Class II

Regulation

21 CFR Part 892.1570

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

• ACUSON RADIOLOGY DOPPLER ACCESSORY by Acuson Computed Sonography
• APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM by Toshiba America Medical Systems, In.C
• TRANSDUCER POSITIONER by PROTEK MEDICAL PRODUCTS, INC.
• EM-TECH Passive Ultrasound Probe Strap by EM-TECH Solutions, Inc.
• ULTRA IMAGE AND ULTRA SCAN by Sonotech, Inc.
• HUMANSCAN 5505700 500395 by Humanscan Company, Ltd.
• THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM by Medison Co., Ltd.
• L8-3 Transducer 11004317 by SIEMENS MEDICAL SOLUTIONS USA, INC.
• ACUSON BL538 TRANSDUCER by Acuson Computed Sonography
• Site-Rite 900013B01 by Bard Access Systems, Inc.

• Needle Guide 667-187

  Class II

  CE/MDR FDA 510(k) K231783 Active Cleared 14 Nov 2023 +1authorizations

• Needle Guide 667-188

  Class II

  CE/MDR FDA 510(k) K231783 Active Cleared 14 Nov 2023 +1authorizations

• CIV-Clear™ Transducer Cover 610-2512

  Class II

  FDA 510(k) K211270 Active Cleared 13 Sep 2021 GUDID on market

• Needle Guide 867-010

  Class II

  FDA 510(k) K231783 Active Cleared 14 Nov 2023 GUDID on market

See all devices from Civco Medical Instruments Co., Inc. →