510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971528Substantially Equivalent

Endoscopically Deliveralbe Ultrasound Point Porbe System (Endoscopy)

FUJIFILM Healthcare Americas Corporation, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971528 is the FDA 510(k) clearance record for ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY), a class II device, cleared for Fujinon, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K971528.

Clearance record

Decision date
Received
(228 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Fujinon, Inc. 399 Park Ave., New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code IYO

Trailing 12 months
10 clearances under product code IYO in the twelve months to November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20262
November 20260