Various X-Ray Tubes

FDA 510(k) K911695 · Comet Ltd. C/O Radiology Resources, Inc.

Substantially Equivalent

510(k) numberK911695

Submission

Device name
Various X-Ray Tubes
Applicant
Comet Ltd. C/O Radiology Resources, Inc.
Switzerland, CH
Received
April 16, 1991
Decision date
June 19, 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
K921130MRX-865ITY · Traditional Mrx-Ray Tube Corp.09/10/1992SE
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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K912338Tube Housing AssembliesITY · Traditional 08/07/1991SE
K910842DI2000/HS-45-150 X-Ray Tube InsertITY · Traditional 03/06/1991SE
K901997X-Ray Tube Housing Assembly, Various ModelsIZH · Traditional 06/06/1990SE
K864749TelamatJAA · Traditional 02/10/1987SE

Questions and answers

When was Various X-Ray Tubes cleared by the FDA?

Various X-Ray Tubes (K911695) received a 510(k) decision of Substantially Equivalent on June 19, 1991, 64 days after the submission was received.

What is the product code of K911695?

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