TV Monitor (P12/17)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K972136 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Perkins Mfg. Co. →

• What is the primary use of the TV Monitor (P12/17) in a clinical setting?

  The TV Monitor (P12/17) is specifically designed for use in radiology procedures, particularly within angiographic X-ray systems. It provides real-time visual output to help radiologists monitor and interpret diagnostic images during procedures like angiography, ensuring accurate imaging during interventions.

• Is the TV Monitor (P12/17) intended for single-use or reusable applications?

  The TV Monitor (P12/17) is supplied as a reusable medical instrument, meaning it is intended for repeated use in controlled clinical environments like radiology departments after proper cleaning and maintenance.

• What screen sizes are available for the TV Monitor (P12/17), and how does this affect its compatibility?

  The TV Monitor (P12/17) comes in two standard cathode-ray tube (CRT) screen sizes: 12 inches and 17 inches. These sizes are designed for integration with angiographic X-ray systems, ensuring compatibility with existing radiology workflows and equipment.

• How was the TV Monitor (P12/17) approved by the FDA, and what does this mean for its regulatory status?

  The TV Monitor (P12/17) received FDA 510(k) clearance (K972136) through the Traditional pathway, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This approval confirms its compliance with FDA regulations for Class 2 devices under code 892.1600, ensuring it meets safety and performance standards for use in radiology.

• What type of environment is the TV Monitor (P12/17) intended for, and why?

  The TV Monitor (P12/17) is intended for use in controlled clinical environments, specifically radiology departments. This is because it is designed to support precise imaging tasks during procedures like angiography, where stability, reliability, and accurate visual output are critical for diagnostic and therapeutic decisions.