510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K153331Substantially Equivalent

SafeCT-29

Medic Vision - Imaging Solutions, Ltd., Tirat Carmel, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153331 is the FDA 510(k) clearance record for SafeCT-29, a class II device, cleared for Medic Vision Imaging Solutions on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 2 510(k) clearances for Medic Vision Imaging Solutions, from to . As of , FDA records show no recalls naming K153331.

Clearance record

Decision date
Received
(180 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Medic Vision Imaging Solutions 3 Yozma, Tirat Carmel, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAK

Trailing 12 months
21 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 20260