510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171207Substantially Equivalent

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

FUJIFILM Healthcare Americas Corporation, Wayne NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171207 is the FDA 510(k) clearance record for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M, a class II device, cleared for Fujifilm Medical Systems U.S.A, Inc. on under FDA product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology). FDA's definition for product code ODG reads: "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...". FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K171207.

Clearance record

Decision date
Received
(261 days to decision)
Product code
ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fujifilm Medical Systems U.S.A, Inc. 10 High Pt. Dr., Wayne NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODG

Trailing 12 months
2 clearances under product code ODG in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ODG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260