Hp Endovaginal/Endorectal Probe, Hp Image Point Ultrasound System

• • Ongoing Z-2348-2025 FDA Class III ·initiated 3 Jul 2025

  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

510(k) Number

K972348 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K862451 Active Cleared 31 Oct 1986

• Hp Sonos 100 Cf Ultrasound Imaging System

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  FDA 510(k) K922184 Active Cleared 30 Jul 1992

• Medical Diag. Ultrasound Instr. 77065

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  FDA 510(k) K842897 Active Cleared 25 Sep 1984

• Model M1403A Telemetry Monitoring Systems (TMS)

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  FDA 510(k) K913533 Active Cleared 7 Nov 1991

• Differential Refractive Index Detector

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  FDA 510(k) K800556 Active Cleared 25 Mar 1980

• Model 80100A, Patient Data Memory

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  FDA 510(k) K781360 Active Cleared 7 Sep 1978

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• What types of examinations is this probe designed for, and how does the single-use or reusable option affect its use?

  This probe is specifically designed for gynecological and rectal examinations, functioning as an endovaginal or endorectal transducer. The single-use or reusable option depends on the model configuration—single-use probes are intended for one-time use to ensure sterility and reduce infection risk, while reusable models require proper cleaning, disinfection, and maintenance between uses as outlined in the manufacturer’s guidelines.

• Can this probe be used with any ultrasound system, or is it compatible only with the HP Image Point Ultrasound System?

  This probe is exclusively authorized for use with the HP Image Point Ultrasound System (model 21336A). It is not compatible with other ultrasound systems, as its design and signal processing are tailored specifically for this host system.

• Is the probe safe to use in an MRI environment, and if not, why?

  No, this probe is not MRI-safe. Its electronic components and design make it unsuitable for use in magnetic resonance imaging environments, as it could interfere with MRI operations or pose safety risks.

• How should the probe be stored, and are there any special handling instructions for maintaining its performance?

  Storage and handling must follow the manufacturer’s guidelines for ultrasound transducers to ensure optimal performance and longevity. This includes proper cleaning (if reusable), protection from physical damage, and adherence to sterility protocols if supplied sterile. Avoid exposure to extreme temperatures or moisture, and store in a clean, dry environment as recommended.

• What does the FDA’s 510(k) clearance (K972348) mean for clinicians or buyers considering this device?

  The FDA’s 510(k) clearance (K972348) indicates that this probe has been determined to be substantially equivalent to a legally marketed predicate device in terms of technology and safety. This means it meets FDA standards for diagnostic ultrasound transducers and has undergone review by the Radiology (RA) Advisory Committee. However, clearance does not imply universal suitability—clinicians should still verify compatibility with their specific workflows and institutional protocols.