Facts Monoblock

FDA 510(k) K981267 · Dynarad Corp.

Substantially Equivalent

510(k) numberK981267

Submission

Device name
Facts Monoblock
Applicant
Dynarad Corp.
Deer Park, NY, US
Received
April 7, 1998
Decision date
May 6, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZX – Collimator, Manual, Radiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1610
Specialty
Radiology

Other 510(k)s with product code IZX

510(k)DeviceApplicantDecision
K110856RalcoIZX · Traditional Ralco S.R.L.08/10/2011SE
K101036Shimadzu Collimator R-20JIZX · Abbreviated Shimadzu Corp.08/26/2010SE
K042840Shimadzu Collimator R-20JIZX · Abbreviated Shimadzu Corp.12/03/2004SE
K031771Shimadzu Collimator R-30HIZX · Abbreviated Shimadzu Corp.08/21/2003SE
K974240Lightline-MIZX · Traditional Wuestec Medical, Inc.12/22/1997SE
K972966Axt 150M Manual Collimator (Axt 150M)IZX · Traditional Applied X-Ray Technologies, Inc.08/21/1997SE
K932134Rinn Universal CollimatorIZX · Traditional Rinn Corp.07/26/1993SE
K912180Model MGB-301 Diaphragm Film 24 X 30 CMIZX · Traditional Instrumentarium Imaging, Inc.10/21/1991SE
K900007R-100-ET Manual CollimatorIZX · Traditional Advantech02/06/1990SE
K896486R-150-ET CollimatorIZX · Traditional Advantech01/23/1990SE

More from Advantech

510(k)DeviceDecision
K000052X-Ray Monoblock, Monoblock XRS-60-330ITY · Traditional 02/10/2000SE
K973833Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic…IZL · Traditional 12/30/1997SE
K932356Nova XM2IZH · Traditional 02/08/1995SE
K941363PhantomIZL · Traditional 07/20/1994SE
K932353HF-110AIZL · Traditional 01/31/1994SE
K9323559150A, 1100FIZL · Traditional 08/03/1993SE
K9323549170, 1170IZL · Traditional 07/23/1993SE
K931725Alpha IIEHD · Traditional 07/14/1993SE

Questions and answers

When was Facts Monoblock cleared by the FDA?

Facts Monoblock (K981267) received a 510(k) decision of Substantially Equivalent on May 6, 1998, 29 days after the submission was received.

What is the product code of K981267?

The FDA product code is IZX – Collimator, Manual, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.