Who is the manufacturer of PHILIPS BV LIBRA?

Philips Medical Systems, Inc. submitted the Traditional clearance for PHILIPS BV LIBRA (K010762).

What is the FDA product code for PHILIPS BV LIBRA?

OXO. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for PHILIPS BV LIBRA?

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

PHILIPS BV LIBRA

K010762 · Philips Medical Systems, Inc. · OXO · Apr 2, 2001 · Radiology

Device Facts

Record ID	K010762
Device Name	PHILIPS BV LIBRA
Applicant	Philips Medical Systems, Inc.
Product Code	OXO · Radiology
Decision Date	Apr 2, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.