Sm-V

510(k) Number

K222951 ↗

FDA product code

IZL

Device class

Class II

Regulation

21 CFR Part 892.1720

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 IZL (System, X-Ray, Mobile).

• OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM by SIEMENS MEDICAL SOLUTIONS USA, INC.
• EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) by Sedecal USA, Inc.
• EzRay M (Model: VMX-P300) by VATECH CO., LTD.
• Sirius Starmobile tiara by Hitachi Medical Systems America, Inc.
• GENERAL ELECTRIC AMX II by Pro-Tronics, Inc.
• Digital Diagnostic Mobile X-ray System by Samsung Electronics Co.,Ltd
• MOBIL-AID AUTOMATIC EXPOSURE CONTROL by Advanced Instrument Development, Inc.
• GENERAL EQUIPMENT COVER by Contour Fabricators, Inc.
• APR MOBILE by Philips Medical Systems (Cleveland), Inc.
• 9150A, 1100F by Dynarad Corp.

• Sedecal Net 4000-St

  Class II

  GUDID on market

• Sedecal SHFR400

  Class I

  CE/MDR GUDID on market

• MobileDiagnost wDR 2.2 Open recall

  Class II

  FDA 510(k) K191813 Active Cleared 2 Aug 2019

• Sedecal Sm-40HF-B-D-C Open recall

  Class II

  CE/MDR FDA 510(k) K090322 Active Cleared 17 Mar 2009 +1authorizations

See all devices from Sedecal., Sa. →