Skip to content

Sled, Finger, Handle

by Biosound Esaote, Inc.

510(k) K971942

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971942 Date23 Jul 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sled, Finger, Handle is an ultrasound accessory designed to support and position ultrasound transducers, particularly for imaging small anatomical structures such as fingers. Classified under the FDA’s product code ITX, this device aids in stabilizing the transducer during radiologic examinations, ensuring consistent imaging quality and operator ergonomics.

Supplied as a reusable accessory for ultrasound systems, the Sled, Finger, Handle is intended for use in radiology settings. It was cleared under FDA 510(k) with K-number K971942 in 1997, falling under regulatory classification II (21 CFR 892.1570). No specific sterility or MRI safety information is provided in the available data, and its design does not include size variations beyond the standard handle configuration.

Other devices from Biosound Esaote, Inc.

See all devices from Biosound Esaote, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sled Finger Handle used for?

    The Sled Finger Handle is an ultrasound accessory designed to support and position ultrasound transducers, particularly for imaging small anatomical structures such as fingers. It helps stabilize the transducer during radiologic examinations to ensure consistent imaging quality and operator ergonomics.

  • Is the Sled Finger Handle a single-use or reusable device?

    The Sled Finger Handle is supplied as a reusable accessory for ultrasound systems. It is designed for repeated use in radiology settings rather than being disposable or single-use.

  • What regulatory classification does the Sled Finger Handle have?

    The Sled Finger Handle was cleared under FDA 510(k) with K-number K971942 in 1997, falling under regulatory classification II (21 CFR 892.1570) and product code ITX. It was determined to be substantially equivalent to predicate devices.

  • Are there different sizes or models of the Sled Finger Handle available?

    According to the available data, the Sled Finger Handle does not include size variations beyond the standard handle configuration. It appears to be manufactured in a single standard design to accommodate typical ultrasound transducer needs for finger imaging.