510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K870748Substantially Equivalent

7.5 Mhz Transrectal (Endorectal) Probe

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

K870748 is the FDA 510(k) clearance record for 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE, a class II device, cleared for Philips Ultrasound, Inc. on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K870748.

Clearance record

Decision date
Received
(44 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Philips Ultrasound, Inc. 2722 S. Fairview, Santa Ana CA
Third party review
No

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260