510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K941093Substantially Equivalent

Smartpacs Filmless Reading and Image Distribution System and Consultation Station

Smartpacs, Simi Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941093 is the FDA 510(k) clearance record for SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION, a class II device, cleared for Smartpacs on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list one 510(k) clearance for Smartpacs. As of , FDA records show no recalls naming K941093.

Clearance record

Decision date
Received
(244 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Smartpacs 1026 Carmel Dr., Simi Valley CA
510(k) summary
Statement
Third party review
No

Clearances, product code LLZ

Trailing 12 months
48 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20267
October 20260