510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K163643Substantially Equivalent

Sirio H3

Masmec SpA, Modugno (Ba), IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163643 is the FDA 510(k) clearance record for SIRIO H3, a class II device, cleared for Masmec Spa on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list one 510(k) clearance for Masmec Spa. As of , FDA records show no recalls naming K163643.

Clearance record

Decision date
Received
(328 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Masmec Spa Via Dei Gigli 21, Modugno (Ba), IT
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