Transducer Dome Cat.# SD-101

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

510(k) Number

K802961 ↗

FDA Product Code

DRQ

Device Class

Class II

Regulation

21 CFR Part 870.2060

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Introducer, Cat. #int-05FR.

  Class II

  FDA 510(k) K771042 Active Cleared 13 Jul 1977

• Transducer Dome DS106

  Class II

  FDA 510(k) K833096 Active Cleared 3 Nov 1983

• Intk-08 8 French Introducer Kit W/Side

  Class II

  FDA 510(k) K812325 Active Cleared 21 Sep 1981

• DNC 162 Vinca-Flo

  Class II

  FDA 510(k) K770048 Active Cleared 14 Jan 1977

• Introducer, Cat. #int-06FR.

  Class II

  FDA 510(k) K771041 Active Cleared 13 Jul 1977

• Tall Floor Stand Tfs-01

  Class II

  FDA 510(k) K831939 Active Cleared 19 Jul 1983

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• What clinical environments is the Transducer Dome (Cat.# SD-101) designed for use in, and why is this important for maintenance?

  The Transducer Dome (Cat.# SD-101) is specifically designed for use in clinical settings such as cardiac catheterization labs and echocardiography suites, where cardiovascular ultrasound imaging is performed. This environment is critical because it requires precise signal amplification and conditioning to ensure accurate diagnostic imaging. Since it is a reusable medical instrument, proper maintenance and calibration are essential to sustain performance, reliability, and patient safety in these high-stakes procedural areas.

• How is the Transducer Dome (Cat.# SD-101) supplied, and what does this mean for its lifecycle management?

  The Transducer Dome (Cat.# SD-101) is supplied as a reusable medical instrument. This means it is intended to be cleaned, disinfected, and maintained between uses rather than being discarded after a single application. Reusability requires adherence to strict infection control protocols and regular servicing to ensure consistent performance and compliance with regulatory standards, particularly under FDA classification 870.2060.

• What regulatory pathway was followed for the FDA clearance of the Transducer Dome (Cat.# SD-101), and what does this indicate about its intended use?

  The Transducer Dome (Cat.# SD-101) received FDA clearance through a 510(k) submission under the DRQ product code, with a decision of Substantially Equivalent by the Cardiovascular Advisory Committee in December 1980. This indicates the device was evaluated against a predicate and determined to have the same intended use and technological characteristics as a previously cleared product. The DRQ code specifically relates to ultrasound equipment, confirming its role in cardiovascular imaging applications.

• Does the Transducer Dome (Cat.# SD-101) come in multiple sizes or models, and if so, how might this affect purchasing decisions?

  The provided data does not specify multiple sizes or models for the Transducer Dome (Cat.# SD-101). However, the OpenFDA registration numbers suggest it may be associated with various facility registrations or lot tracking identifiers, but these do not imply different physical configurations. If compatibility with specific ultrasound systems or transducer types is a concern, purchasers should verify compatibility with their existing equipment before acquisition.