Rover

System, X-ray, Mobile

Micro-X Ltd.

The following data is part of a premarket notification filed by Micro-x Ltd. with the FDA for Rover.

Pre-market Notification Details

• Device ID: K201488
• 510k Number: K201488
• Device Name: Rover
• Classification: System, X-ray, Mobile
• Applicant: Micro-X Ltd. A14 6 MAB Eastern Promenade, Tonsley (clovelly Park), AU 5042
• Contact: Mark Norman
• Correspondent: Daniel Kamm; Kamm & Associates 8870 Ravello Ct Naples, FL 34114
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-04
• Decision Date: 2020-07-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00935712300004	K201488	000