PET-TV X-Ray Image Intensifier System

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

510(k) Number

K771485 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Pet-Scope II Model Dis-1611

  Class II

  FDA 510(k) K801166 Active Cleared 26 Jun 1980

• Pet-Scope

  Class II

  FDA 510(k) K761285 Active Cleared 29 Dec 1976

• What is the primary purpose of the PET-TV X-Ray Image Intensifier System in a clinical setting?

  The PET-TV X-Ray Image Intensifier System is designed to enhance low-light X-ray images for real-time visualization during fluoroscopic procedures. By converting X-ray photons into visible light, it improves diagnostic clarity in radiology, making it easier to observe internal structures during imaging.

• Is the PET-TV X-Ray Image Intensifier System intended for single-use or reusable applications?

  The PET-TV X-Ray Image Intensifier System is explicitly described as a reusable medical device. This means it is built for repeated use in radiology settings after proper cleaning and maintenance, rather than being discarded after a single procedure.

• How is the regulatory clearance for this device categorized, and what does that mean for its use?

  The PET-TV X-Ray Image Intensifier System holds a traditional 510(k) clearance (K771485) under FDA regulation 892.1650, classifying it as a Class II device. This means it has been determined to be substantially equivalent to a legally marketed device and is subject to general controls, with additional performance standards to ensure safety and effectiveness in fluoroscopic imaging.

• Are there multiple models or variations of this device, and if so, how are they identified?

  The device data lists multiple FEI numbers (e.g., 3013099020, 3005706667, etc.), which likely correspond to different models, configurations, or variants of the PET-TV X-Ray Image Intensifier System. These identifiers are used for regulatory tracking and may reflect variations in technical specifications or features, though the core function remains consistent as an image-intensified X-ray system.

• What should clinicians or facilities consider regarding storage or maintenance of this reusable device?

  Since the PET-TV X-Ray Image Intensifier System is reusable, proper storage and maintenance protocols are critical to ensure longevity and performance. While specific storage conditions (e.g., temperature, humidity) aren’t detailed in the data, reusable medical devices typically require adherence to manufacturer guidelines for cleaning, sterilization (if applicable), and environmental protection to prevent damage or contamination before reuse in fluoroscopic procedures.