Dcd-1 (Digital Contour Detect-Radiat Therapy) Syst

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

510(k) Number

K883317 ↗

FDA Product Code

IXI

Device Class

Class II

Regulation

21 CFR Part 892.5710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the DCD-1 Digital Contour Detect-Radiation Therapy System in a clinical setting?

  The DCD-1 is designed as a Block, Beam-Shaping device specifically for radiation therapy. Its main function is to assist in shaping and directing radiation beams with precision, helping clinicians achieve accurate contour detection during treatment planning and delivery in radiology environments. This ensures targeted radiation therapy for improved therapeutic outcomes.

• How is the DCD-1 Digital Contour Detect-Radiation Therapy System regulated, and what does that mean for its use?

  The DCD-1 is classified as a Class II medical device and has received FDA 510(k) clearance under K-number K883317, determined to be *substantially equivalent* to a predicate device. This means it has undergone regulatory review by the FDA to ensure safety and effectiveness for its intended use in radiation therapy, specifically in radiology settings. The clearance also aligns with Medical Device Regulation 892.5710, confirming its compliance with U.S. standards.

• Is the DCD-1 system reusable or single-use, and what does that imply for its maintenance?

  The available data does not explicitly state whether the DCD-1 is single-use or reusable. Without this specification, facilities must follow manufacturer guidelines (provided in the user manual or instructions for use) to determine proper handling, cleaning, and sterilization protocols if reuse is intended. Always verify with the manufacturer or consult their documentation to ensure compliance with infection control and device integrity standards.

• What types of radiation therapy environments is the DCD-1 intended for, and how does that influence its application?

  The DCD-1 is intended for use in radiology environments, as indicated by its regulatory classification and advisory committee designation. This means it is specifically engineered to support precise beam shaping and contour detection in facilities where radiation therapy is administered, such as oncology centers, radiation oncology departments, or specialized radiology clinics. Its design ensures compatibility with standard radiation therapy workflows in these settings.

• Are there multiple models or configurations of the DCD-1 system, and how can I identify the correct one for my facility?

  The data lists multiple registration numbers (e.g., 3030977776, 3022973841, etc.) associated with the DCD-1, which may correspond to different models or variations of the system. While the core function remains the same—beam shaping for radiation therapy—facilities should verify the exact specifications, dimensions, or features of the model they require by consulting the manufacturer’s documentation or contacting S & S X-Ray Products, Inc. directly. This ensures compatibility with your facility’s equipment and treatment protocols.