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FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

by Fujifilm Medical Systems U.S.A, Inc.

510(k) K171207

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171207 Date11 Jan 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
ODG
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is an endoscopic ultrasound system consisting of a processor and a probe. It is designed for use in gastroenterology and urology procedures to provide ultrasound observation during examinations. The system is compact and can be used alone or in conjunction with endoscopic systems.

The device is supplied as a system with five components including the processor (SP-900) and probe (PB2020-M). It is a Class II medical device with FDA 510(k) clearance (K171207) and is regulated under product code ODG. The device is intended for use by medical professionals following safety precautions and operational guidelines outlined in the provided manual.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What clinical specialties is the SP-900 system intended for?

    The system is cleared for gastroenterology and urology procedures, allowing clinicians to obtain real‑time ultrasound images during endoscopic examinations in those specialties.

  • How is the system supplied and what components are included?

    It is delivered as a complete system containing five items, the core being the SP-900 processor and the PB2020-M ultrasonic probe, together with the accessories required for connection and operation.

  • Is the SP-900/ PB2020-M system single‑use or reusable?

    Both the processor and probe are designed for repeated clinical use. They must be cleaned and disinfected according to the manufacturer’s manual and applicable safety guidelines before each procedure.

  • Can the processor be used without an endoscope?

    Yes, the SP-900 is a compact unit that can operate independently, but it is also compatible with existing endoscopic platforms, giving flexibility to integrate into current endoscopy suites.

  • What regulatory classification does this device have?

    The system is classified as a Class II medical device and has received FDA 510(k) clearance (K171207) under product code ODG, indicating it is substantially equivalent to a legally marketed predicate.