510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033774Substantially Equivalent

CT-Mass

Medis Medical Imaging Systems, B.V., Leiden, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033774 is the FDA 510(k) clearance record for CT-MASS, a class II device, cleared for Medis Medical Imaging Systems BV on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 18 510(k) clearances for Medis Medical Imaging Systems BV, from to . As of , FDA records show no recalls naming K033774.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Medis Medical Imaging Systems BV Schuttersveld 9, Leiden, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAK

Trailing 12 months
20 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 20263
October 20260