510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900660Substantially Equivalent

Tomoscan Stereotaxis Simulation Software

Philips North America LLC, Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900660 is the FDA 510(k) clearance record for TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE, a class II device, cleared for Philips Medical Systems North America, Inc. on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K900660.

Clearance record

Decision date
Received
(32 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems North America, Inc. 710 Bridgeport Ave., Shelton CT
Third party review
No

Clearances, product code JAK

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