MRX-865

FDA 510(k) K921130 · Mrx-Ray Tube Corp.

Substantially Equivalent

510(k) numberK921130

Submission

Device name
MRX-865
Applicant
Mrx-Ray Tube Corp.
Arlington, TX, US
Received
March 10, 1992
Decision date
September 10, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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

Other 510(k)s with product code ITY

510(k)DeviceApplicantDecision
K000052X-Ray Monoblock, Monoblock XRS-60-330ITY · Traditional Dynarad Corp.02/10/2000SE
K933162MRX-750ITY · Traditional Mrx Corp.10/07/1993SE
K923094MolybdenumITY · Traditional Southeastern Medical Diagnostics, Inc.03/04/1993SE
K923141Philips Pre-Filter OptionITY · Traditional Philips Medical Systems, Inc.01/21/1993SE
K921129MRX-700ITY · Traditional Mrx-Ray Tube Corp.10/05/1992SE
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
K920387CIRCLEXO.3T X-Ray Tube AssemblyITY · Traditional Shimadzu Medical Systems04/14/1992SE

More from Shimadzu Medical Systems

510(k)DeviceDecision
K921129MRX-700ITY · Traditional 10/05/1992SE

Questions and answers

When was MRX-865 cleared by the FDA?

MRX-865 (K921130) received a 510(k) decision of Substantially Equivalent on September 10, 1992, 184 days after the submission was received.

What is the product code of K921130?

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