510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965161Substantially Equivalent

Smiic (Sectra Medical Image Input Controller)

Sectra-Imtec AB, Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965161 is the FDA 510(k) clearance record for SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER), a class I device, cleared for Sectra-Imtec AB on under FDA product code LMD (System, Digital Image Communications, Radiological). FDA's definition for product code LMD reads: "A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple...". FDA records list 14 510(k) clearances for Sectra-Imtec AB, from to . As of , FDA records show no recalls naming K965161.

Clearance record

Decision date
Received
(79 days to decision)
Product code
LMD System, Digital Image Communications, Radiological
Regulation
21 CFR 892.2020
Device class
Class I
Review panel
Radiology
Applicant
Sectra-Imtec AB 6741 Grant Ln., Plano TX
510(k) summary
Summary
Third party review
No

Clearances, product code LMD

Trailing 12 months

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

FDA records show no clearances under product code LMD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMD, 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