SIS-300(N)-DIA Scan

FDA 510(k) K926434 · Micro-Focus Imaging., Inc.

Substantially Equivalent

510(k) numberK926434

Submission

Device name
SIS-300(N)-DIA Scan
Applicant
Micro-Focus Imaging., Inc.
Wheeling, IL, US
Received
December 23, 1992
Decision date
March 18, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

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Questions and answers

When was SIS-300(N)-DIA Scan cleared by the FDA?

SIS-300(N)-DIA Scan (K926434) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 85 days after the submission was received.

What is the product code of K926434?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.