Superpett

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

510(k) Number

K843366 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Diolase

  Class I

  FDA 510(k) K904753 Active Cleared 9 Nov 1990

• Mm-22 Microtron, MM50 Microtron

  Class II

  FDA 510(k) K900434 Active Cleared 23 Oct 1990

• Rfa A-300

  Class II

  FDA 510(k) K934303 Active Cleared 9 Aug 1994

• Dpd-3

  Class II

  FDA 510(k) K942092 Active Cleared 29 Jul 1994

• Dpd-510 Therapeutic Radiation Dosimeter

  Class II

  FDA 510(k) K925133 Active Cleared 4 Jan 1993

• Scandiplan Version 338

  Class II

  FDA 510(k) K914926 Active Cleared 28 May 1992

• What is the primary clinical use of the Superpett device in a medical setting?

  The Superpett is a positron emission tomography (PET) imaging system designed for detecting gamma rays emitted by radiotracers. It generates cross-sectional images of metabolic activity within the body, primarily used in radiology for diagnostic purposes, such as identifying areas of abnormal metabolic function.

• Is the Superpett device single-use or reusable, and what does this mean for maintenance?

  The Superpett is explicitly described as a reusable medical system. This means it is intended for repeated use across multiple patients, requiring proper cleaning, calibration, and maintenance protocols to ensure accuracy and safety in PET imaging.

• What regulatory pathway was followed for the Superpett’s FDA clearance, and what does this imply for its use?

  The Superpett received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SESE) under the Traditional clearance type. This implies it was determined to be as safe and effective as a legally marketed device already on the market, and it is regulated under 21 CFR 892.1200 for radiology devices. The clearance was granted by the FDA’s Radiology (RA) Advisory Committee in 1984.

• Does the Superpett require any special handling or storage conditions, such as sterility or environmental considerations?

  The available data does not specify any sterility requirements for the Superpett, as it is a reusable imaging system rather than a disposable or patient-contact device. However, since it operates in radiology settings, proper maintenance, calibration, and adherence to radiation safety protocols are critical. No MRI safety information is provided, so it should not be used in MRI environments unless verified separately.

• Are there multiple models or configurations of the Superpett, and how would a buyer determine the correct one for their facility?

  The Superpett appears to have multiple FEI numbers (e.g., 3015232217, 3002808139, etc.) listed under its registration, which may correspond to different models, configurations, or updates over time. Buyers should consult Scanditronix, Inc. or verify compatibility with their facility’s imaging needs, radiotracer protocols, and physical space requirements to select the appropriate model.