Tangent II

FDA 510(k) K883974 · Fischer Imaging Corp.

Substantially Equivalent

510(k) numberK883974

Submission

Device name
Tangent II
Applicant
Fischer Imaging Corp.
Denver, CO, US
Received
September 20, 1988
Decision date
October 20, 1988
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

510(k)DeviceApplicantDecision
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

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K021113MammopathMWP · Traditional 06/13/2002SE
K981414LC PositionerJAA · Traditional 07/16/1998SE
K973400Mammotest Adapter DriverIZH · Traditional 11/10/1997SE
K964806MD-1835IXL · Traditional 03/04/1997SE
K961207Ep-X BiplaneJAA · Traditional 08/20/1996SE
K961022Tangent Vi TableIXR · Traditional 05/03/1996SE
K950291Digital 625HFIZO · Traditional 03/23/1995SE
K945619Athena HFXIZH · Traditional 03/23/1995SE
K944150Micro X-65 HFIZO · Traditional 09/16/1994SE

Questions and answers

When was Tangent II cleared by the FDA?

Tangent II (K883974) received a 510(k) decision of Substantially Equivalent on October 20, 1988, 30 days after the submission was received.

What is the product code of K883974?

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