Toshiba, Smit Roentgen

FDA 510(k) K870071 · North American Imaging, Inc.

Substantially Equivalent

510(k) numberK870071

Submission

Device name
Toshiba, Smit Roentgen
Applicant
North American Imaging, Inc.
Monument, CO, US
Received
January 8, 1987
Decision date
January 21, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ITY – Assembly, Tube Housing, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1760
Specialty
Radiology

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K921129MRX-700ITY · Traditional Mrx-Ray Tube Corp.10/05/1992SE
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K921316MG-1001 Tube Housing AssemblyITY · Traditional Magma Corp.06/22/1992SE
K920731X-Ray Tube Assembly CIRCLEX1.2UGITY · Traditional Shimadzu Medical Systems05/29/1992SE
K920724High Speed Rotation Starter SA-50ITY · Traditional Shimadzu Medical Systems04/27/1992SE
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Questions and answers

When was Toshiba, Smit Roentgen cleared by the FDA?

Toshiba, Smit Roentgen (K870071) received a 510(k) decision of Substantially Equivalent on January 21, 1987, 13 days after the submission was received.

What is the product code of K870071?

The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.