Hofmann-Nagel (Hofna) X-Ray Tubes

FDA 510(k) K900367 · Hofmann

Substantially Equivalent

510(k) numberK900367

Submission

Device name
Hofmann-Nagel (Hofna) X-Ray Tubes
Applicant
Hofmann
Irvine, CA, US
Received
January 26, 1990
Decision date
February 26, 1990
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

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
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

Questions and answers

When was Hofmann-Nagel (Hofna) X-Ray Tubes cleared by the FDA?

Hofmann-Nagel (Hofna) X-Ray Tubes (K900367) received a 510(k) decision of Substantially Equivalent on February 26, 1990, 31 days after the submission was received.

What is the product code of K900367?

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