Remote-Controlled Universal Diag. Table RS-100

FDA 510(k) K874639 · Shimadzu Precision Instruments, Inc.

Substantially Equivalent

510(k) numberK874639

Submission

Device name
Remote-Controlled Universal Diag. Table RS-100
Applicant
Shimadzu Precision Instruments, Inc.
Torrance, CA, US
Received
November 12, 1987
Decision date
December 4, 1987
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 Remote-Controlled Universal Diag. Table RS-100 cleared by the FDA?

Remote-Controlled Universal Diag. Table RS-100 (K874639) received a 510(k) decision of Substantially Equivalent on December 4, 1987, 22 days after the submission was received.

What is the product code of K874639?

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