Rover

510(k) Number

K201488 ↗

FDA product code

IZL

FDA applicant

Micro-X , Ltd.

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).

• Remex KA6 by REMEDI CO., LTD.
• PX-100 PORTABLE X-RAY GENERATOR by Acoma Medical Imaging, Inc.
• GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR by General Electric Co.
• EZER, Portable X-ray System by LIVERMORETECH,INC
• VMX MOBILE X-RAY SYSTEM by GE MEDICAL SYSTEMS, INC.
• MINXRAY, MODEL HF120/60H POWERPLUS by Minxray, Inc.
• MINXRAY, MODEL HF100H+ by Minxray, Inc.
• ACU-RAY HF SERIES PORTABLE X-RAY UNIT by Sterne Equipment Co., Ltd.
• Portable DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
• AMX Navigate Mobile X-Ray System by GE Medical Systems, LLC

• Micro-X Rover Open recall

  Class II

  FDA 510(k) K211423 Active Cleared 21 May 2021 GUDID on market

• Rover Open recall

  Class II

  FDA 510(k) K211423 Active Cleared 21 May 2021

• Micro-X Rover Open recall

  Class II

  CE/MDR FDA 510(k) K211423 Active Cleared 21 May 2021 +1authorizations

• Micro-X Rover Open recall

  Class II

  FDA 510(k) K211423 Active Cleared 21 May 2021 GUDID on market

See all devices from Micro-X, Ltd. →