Protec 1024

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

510(k) Number

K963730 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• What is the primary clinical use of the Protec 1024 system in radiology settings?

  The Protec 1024 is designed for imaging gamma-emitting radioactive tracers within the human body. It captures radiation distribution using a multiwire proportional detector, enabling precise visualization of tracer uptake. This is primarily used for diagnostic purposes in radiology, such as assessing organ function, detecting abnormalities, or monitoring physiological processes.

• Is the Protec 1024 system reusable or single-use, and what does this mean for maintenance?

  The Protec 1024 is supplied as a reusable medical system. This means it is intended for repeated use across multiple patients, provided it undergoes proper cleaning, disinfection, and maintenance as outlined by the manufacturer’s instructions. Reusability helps ensure consistent performance and cost-effectiveness in clinical settings.

• What regulatory pathway was followed for FDA clearance of the Protec 1024, and what does this imply for its use?

  The Protec 1024 received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type, with a decision code of SESE (Substantially Equivalent). This implies the device was determined to be substantially equivalent to a legally marketed predicate device in terms of technology and safety. It is authorized for use in radiology settings and must comply with regulatory standards for radiation-emitting equipment, including those outlined in 21 CFR 892.1200.

• What components does the Protec 1024 system include, and how are they integrated?

  The Protec 1024 consists of three key components: a radiation detection head (which captures gamma emissions), mobile electronics (for real-time image processing), and a computer system (for acquisition, control, and visualization of the imaging data). These components work together to enable precise diagnostic imaging of radioactive tracers within the body, with the detection head interfacing directly with the electronics and computer for seamless data processing.

• What special considerations should be taken into account when storing or transporting the Protec 1024?

  While the device data does not specify storage conditions, as a reusable radiation-emitting medical system, the Protec 1024 should be stored in a secure, controlled environment to prevent unauthorized access and ensure proper calibration. Transport should follow guidelines for radiation safety, including shielding and compliance with local regulations to minimize exposure risks. Always refer to the manufacturer’s instructions for specific storage and handling protocols.