DRTS Image Intensifier Drape

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

510(k) Number

K973073 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K041846 Active Cleared 26 Aug 2004

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• Minrad Drts Light Saber Syringe

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  FDA 510(k) K981140 Active Cleared 25 Jun 1998

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• Drts Remote Control Drape

  Class II

  FDA 510(k) K973067 Active Cleared 16 Oct 1997

See all devices from Minrad, Inc. →

• What is the primary purpose of the DRTS Image Intensifier Drape in a clinical setting?

  The DRTS Image Intensifier Drape is designed as a sterile protective cover specifically for the image intensifier end of mobile C-Arm X-ray systems. Its main purpose is to act as a physical barrier to maintain a sterile field during surgical or diagnostic procedures in radiology settings, preventing contamination of the image intensifier.

• Is the DRTS Image Intensifier Drape intended for single-use or repeated use?

  The DRTS Image Intensifier Drape is explicitly designed for single-use only. It is supplied sterile and intended to be applied once to protect the image intensifier from contamination, ensuring a sterile field during procedures.

• How should the DRTS Image Intensifier Drape be stored before use?

  While the data does not specify storage conditions, the drape is supplied sterile, so it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility until use.

• What regulatory pathway was followed for FDA clearance of this device?

  The DRTS Image Intensifier Drape received FDA 510(k) clearance (K973073) under the Radiology advisory committee in 1997. It was classified as a Class II device under special controls and was determined to be substantially equivalent to a predicate device through a traditional 510(k) review.