Who is the manufacturer of Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM?

Control-X Medical, Inc. submitted the Traditional clearance for Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM (K102680).

What is the FDA product code for Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM?

KPR. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM?

510(k) clearance (submission type: Traditional).

Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM

K102680 · Control-X Medical, Inc. · KPR · Oct 22, 2010 · Radiology

Device Facts

Record ID	K102680
Device Name	Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
Applicant	Control-X Medical, Inc.
Product Code	KPR · Radiology
Decision Date	Oct 22, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.