Horizontal Radiographic 4/WAY Floating

FDA 510(k) K792169 · Bennett X-Ray Corp.

Substantially Equivalent

510(k) numberK792169

Submission

Device name
Horizontal Radiographic 4/WAY Floating
Applicant
Bennett X-Ray Corp.
Mchenry, IL, US
Received
October 29, 1979
Decision date
December 10, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZZ – Table, Radiographic, Non-Tilting, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Specialty
Radiology

Other 510(k)s with product code IZZ

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K971452Multix Top/Pro Radiographic X-Ray TableIZZ · Traditional Siemens Medical Solutions USA, Inc.05/14/1997SE
K952701Med-Tron SPECT Imaging TableIZZ · Traditional Med-Tron Products, Inc.07/06/1995SE
K951315Catheterization Table KS-60IZZ · Traditional Shimadzu Medical Systems05/11/1995SE
K951053Angiorex CAT-350BIZZ · Traditional Toshiba America Medical Systems, In.C04/06/1995SE
K943926Rapido 2000 Automatic Radiographic TableIZZ · Traditional Philips Medical Systems (Cleveland), Inc.11/28/1994SE
K930273AlphaIZZ · Traditional Raymax Medical Corp.07/13/1993SE
K924444B-4 Four-Way Radiographic TableIZZ · Traditional Control-X, Inc.02/05/1993SE
K925174Shimadzu Radiographic Table BK-100IZZ · Traditional Shimadzu Medical Systems11/27/1992SE
K921501Deluxe C Arm Radiological Table, Model #056-004IZZ · Traditional Biodan Medical Systems, Ltd.05/15/1992SE
K920732Catherization KS-50IZZ · Traditional Shimadzu Medical Systems04/16/1992SE

More from Shimadzu Medical Systems

510(k)DeviceDecision
K964576Profile Mammography System (M-Pro)IZH · Traditional 01/10/1997SE
K952672Vertical Integrated Perfect View (Vip) Radiographic SystemKPR · Traditional 07/13/1995SE
K944978Bennett X-Ray Digital Spot Imaging System Model M-DsiIZH · Traditional 05/03/1995SE
K945962Bennett X-Ray Profile Positioning Paddle for MammographyIZH · Traditional 04/03/1995SE
K945749Bennett X-Ray Tomography SystemIZF · Traditional 02/15/1995SE
K945731HFQ High Frequency Radiographic and Fluroscopic GeneratorsIZO · Traditional 02/15/1995SE
K940701Bennett Mammography Positioning Chair Model No. M-PchIZH · Traditional 04/28/1994SE
K935649Whis-Rad Tubstand Structure/Mobile Patient TrolleyKPR · Traditional 02/09/1994SE
K935068Radiographic Generator Hfq-WhisIZO · Traditional 12/13/1993SE
K925725Contour Mammography System, Model Number M-CtrIZH · Traditional 02/26/1993SE

Questions and answers

When was Horizontal Radiographic 4/WAY Floating cleared by the FDA?

Horizontal Radiographic 4/WAY Floating (K792169) received a 510(k) decision of Substantially Equivalent on December 10, 1979, 42 days after the submission was received.

What is the product code of K792169?

The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.