510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K897098Substantially Equivalent

Siemens Endo-P-Probe

Siemens Medical Solutions USA, Inc., San Ramon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897098 is the FDA 510(k) clearance record for SIEMENS ENDO-P-PROBE, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K897098.

Clearance record

Decision date
Received
(64 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Siemens Medical Solutions USA, Inc. 2527 Camino Ramon, San Ramon CA
Third party review
No

Clearances, product code ITX

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