Cleared Traditional

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

K231666 · Fujifilm Healthcare Americas Corporation · Radiology
Dec 2023
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K231666 is an FDA 510(k) clearance for the Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L), a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on December 13, 2023, 189 days after receiving the submission on June 7, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K231666 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2023
Decision Date December 13, 2023
Days to Decision 189 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

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