510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880965Substantially Equivalent

Somatom Plus

Siemens Medical Solutions USA, Inc., Iselin NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880965 is the FDA 510(k) clearance record for SOMATOM PLUS, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K880965.

Clearance record

Decision date
Received
(20 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Siemens Medical Solutions USA, Inc. 186 Wood Ave. S., Iselin NJ
Third party review
No

Clearances, product code JAK

Trailing 12 months
22 clearances under product code JAK in the twelve months to October 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20264
October 20261