510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K864980Substantially Equivalent

3Mhz Annular Array

Philips North America LLC, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864980 is the FDA 510(k) clearance record for 3MHZ ANNULAR ARRAY, a class II device, cleared for Philips Ultrasound, Inc. on under FDA product code JOP (Transducer, Ultrasonic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K864980.

Clearance record

Decision date
Received
(140 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Ultrasound, Inc. 2722 S. Fairview, Santa Ana CA
Third party review
No

Clearances, product code JOP

Trailing 12 months

FDA records hold no clearances under product code JOP in the trailing twelve months.

FDA records show no clearances under product code JOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260