Programmable Video Controller Model PK2060

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

510(k) Number

K904986 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Grundig Electronics Various Models

  Class II

  FDA 510(k) K915232 Active Cleared 9 Jan 1992

• Cine Camera Control Model PK2037

  Class II

  FDA 510(k) K896615 Active Cleared 4 Jan 1990

• Display Processor - Model IDP5100

  Class II

  FDA 510(k) K920550 Active Cleared 13 Apr 1992

• 1 Video Tape Recorder Model Bk-224 H

  Class II

  FDA 510(k) K892934 Active Cleared 20 Jul 1989

• Philips RT250 Collimator (PK8050)

  Class II

  FDA 510(k) K885126 Active Cleared 1 Jun 1989

• Video Annotator Model PK2310

  Class II

  FDA 510(k) K910384 Active Cleared 16 Apr 1991

See all devices from Perkins Mfg. Co. →

• What is the primary purpose of the Programmable Video Controller Model PK2060 in a radiology setting?

  The Programmable Video Controller Model PK2060 is designed to control and manage video signals in fluoroscopic imaging systems. It enhances image quality and operational flexibility during radiographic procedures by allowing programmable adjustments, ensuring clearer visual output for diagnostic accuracy.

• Is the Programmable Video Controller Model PK2060 intended for single-use or can it be reused?

  The device is explicitly supplied as a reusable unit, meaning it is not designed for single-use. This classification aligns with its regulatory documentation under FDA 510(k) clearance, where reuse is accounted for in its compliance.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Programmable Video Controller Model PK2060 received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device. This means the manufacturer demonstrated that it is substantially equivalent to a legally marketed device already on the market, ensuring it meets established safety and performance standards for use in radiology settings.

• Does this device require any special handling or storage conditions?

  The available data does not specify any special handling or storage conditions for the Programmable Video Controller Model PK2060. However, since it is reusable, it should be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and longevity in fluoroscopic imaging systems.

• Are there any known compatibility concerns with MRI environments for this device?

  The provided data does not include any information regarding MRI safety for the Programmable Video Controller Model PK2060. If MRI compatibility is a concern, it would be important to consult the manufacturer’s documentation or verify with Perkins Mfg. Co. before use in an MRI environment.