Cleared Traditional

K171207 - FUJIFILM Ultrasonic Processor SP-900 an...

K171207 is the FDA 510(k) clearance for FUJIFILM Ultrasonic Processor SP-900 an... by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ODG) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K171207 · Fujifilm Medical Systems U.S.A, Inc. · Gastroenterology & Urology device
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Jan 2018
Decision
261d
Days
Class 2
Risk

K171207 is an FDA 510(k) clearance for the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on January 11, 2018 after a review of 261 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Medical Systems U.S.A, Inc. devices

Submission Details

510(k) Number K171207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2017
Decision Date January 11, 2018
Days to Decision 261 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 130d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODG Endoscopic Ultrasound System, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 36
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K171207.
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Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K173184 · Boston Scientific · Oct 2017
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K172309 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2017
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
K162447 · Pentax of America, Inc. · Apr 2017