510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011617Substantially Equivalent

Lifejet Printer 400

Ferrania S.p.A. Stabilimento di Ferrania, Ferrania, Savona, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011617 is the FDA 510(k) clearance record for LIFEJET PRINTER 400, a class II device, cleared for Ferrania S.P.A. Stabilimento DI Ferrania on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list one 510(k) clearance for Ferrania S.P.A. Stabilimento DI Ferrania. As of , FDA records show no recalls naming K011617.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Ferrania S.P.A. Stabilimento DI Ferrania 57 Viale Della Liberta, Ferrania, Savona, IT
510(k) summary
Summary
Third party review
Yes

Clearances, product code LMC

Trailing 12 months

FDA records hold no clearances under product code LMC in the trailing twelve months.

FDA records show no clearances under product code LMC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260