Niobi-X Radiation Reduction Filter

FDA 510(k) K882939 · American Canadian Products, Inc.

Substantially Equivalent

510(k) numberK882939

Submission

Device name
Niobi-X Radiation Reduction Filter
Applicant
American Canadian Products, Inc.
Tampa, FL, US
Received
July 13, 1988
Decision date
November 4, 1988
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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K920731X-Ray Tube Assembly CIRCLEX1.2UGITY · Traditional Shimadzu Medical Systems05/29/1992SE
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Questions and answers

When was Niobi-X Radiation Reduction Filter cleared by the FDA?

Niobi-X Radiation Reduction Filter (K882939) received a 510(k) decision of Substantially Equivalent on November 4, 1988, 114 days after the submission was received.

What is the product code of K882939?

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