Who is the manufacturer of THE PHARAOH COMPENSATING FILTER?

Octostop, Inc. submitted the Traditional clearance for THE PHARAOH COMPENSATING FILTER (K963941).

What is the FDA product code for THE PHARAOH COMPENSATING FILTER?

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

What is the regulatory pathway for THE PHARAOH COMPENSATING FILTER?

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

THE PHARAOH COMPENSATING FILTER

K963941 · Octostop, Inc. · KPR · Nov 27, 1996 · Radiology

Device Facts

Record ID	K963941
Device Name	THE PHARAOH COMPENSATING FILTER
Applicant	Octostop, Inc.
Product Code	KPR · Radiology
Decision Date	Nov 27, 1996
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.