DFS-700

FDA 510(k) K945388 · Shimadzu Corp.

Substantially Equivalent

510(k) numberK945388

Submission

Device name
DFS-700
Applicant
Shimadzu Corp.
Torrance, CA, US
Received
November 3, 1994
Decision date
January 30, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was DFS-700 cleared by the FDA?

DFS-700 (K945388) received a 510(k) decision of Substantially Equivalent on January 30, 1995, 88 days after the submission was received.

What is the product code of K945388?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.