Koordinat 3D

FDA 510(k) K790783 · Siemens Corp.

Substantially Equivalent

510(k) numberK790783

Submission

Device name
Koordinat 3D
Applicant
Siemens Corp.
Mchenry, IL, US
Received
April 23, 1979
Decision date
May 7, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KXJ – Table, Radiologic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Specialty
Radiology

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Questions and answers

When was Koordinat 3D cleared by the FDA?

Koordinat 3D (K790783) received a 510(k) decision of Substantially Equivalent on May 7, 1979, 14 days after the submission was received.

What is the product code of K790783?

The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.