X-Ray Tube Housing Assembly Soredex Dc/Cir 51

FDA 510(k) K910276 · Inmark Corp.

Substantially Equivalent

510(k) numberK910276

Submission

Device name
X-Ray Tube Housing Assembly Soredex Dc/Cir 51
Applicant
Inmark Corp.
Norwalk, CT, US
Received
January 23, 1991
Decision date
March 6, 1991
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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K923141Philips Pre-Filter OptionITY · Traditional Philips Medical Systems, Inc.01/21/1993SE
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
K920723High Speed Rotation Starter SA-40ITY · Traditional Shimadzu Medical Systems04/27/1992SE

More from Shimadzu Medical Systems

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K910308X-Ray Tube Housing Assembly Polarix II Gen/Xo 110ITY · Traditional 03/27/1991SE
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K894413X-Ray Tube Housing Assembly, Various ModelsITY · Traditional 09/22/1989SE

Questions and answers

When was X-Ray Tube Housing Assembly Soredex Dc/Cir 51 cleared by the FDA?

X-Ray Tube Housing Assembly Soredex Dc/Cir 51 (K910276) received a 510(k) decision of Substantially Equivalent on March 6, 1991, 42 days after the submission was received.

What is the product code of K910276?

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