Cleared Traditional

L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM

K973079 · Acuson Corp. · Radiology
Nov 1997
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K973079 is an FDA 510(k) clearance for the L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on November 5, 1997, 79 days after receiving the submission on August 18, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K973079 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1997
Decision Date November 05, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code ITX — Transducer, Ultrasonic, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

Similar Devices — ITX Transducer, Ultrasonic, Diagnostic

All 408
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
K250883 · Olympus Medical Systems Corporation · Sep 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
K250762 · Olympus Medical Systems Corporation · Jul 2025
Mendaera Guidance System
K250524 · Mendaera, Inc. · Jul 2025
Accuro? 3S Needle Guide Kit
K250469 · Rivanna Medical, Inc. · Jun 2025
Ultrasound Transducer Cover
K241662 · Vitrolife Sweden AB · Aug 2024
UltraDrape UGPIV Barrier and Securement (34-15)
K233965 · Parker Laboratories, Inc. · Aug 2024