E-Z Lift Crank Imaging Table

FDA 510(k) K912181 · Med-Tron Products, Inc.

Substantially Equivalent

510(k) numberK912181

Submission

Device name
E-Z Lift Crank Imaging Table
Applicant
Med-Tron Products, Inc.
Miller Place, NY, US
Received
May 16, 1991
Decision date
July 17, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IYZ – Bed, Scanning, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1350
Specialty
Radiology

Other 510(k)s with product code IYZ

510(k)DeviceApplicantDecision
K920962Multiple Accessory to Gamma CamerasIYZ · Traditional Nu Age Products04/17/1992SE
K915541SPECT Table, Model #056-760IYZ · Traditional Atomic Products Corp.01/17/1992SE
K911691Xyz Crank Imaging TableIYZ · Traditional Med-Tron Products, Inc.08/09/1991SE
K912481Ect Carbon Fiber Pallet, ModificationIYZ · Traditional Siemens Gammasonics, Inc.08/02/1991SE
K912286Cardiac SPECT PalletIYZ · Traditional Siemens Gammasonics, Inc.08/02/1991SE
K912135Xy Imaging TableIYZ · Traditional Med-Tron Products, Inc.07/17/1991SE
K911564E-Z Lift Imaging Table with Foot PumpIYZ · Traditional Med-Tron Products, Inc.07/15/1991SE
K911561Xyz Imaging Table with Foot PumpIYZ · Traditional Med-Tron Products, Inc.07/15/1991SE
K903901Scanning CotIYZ · Traditional Med-Tron Products, Inc.09/21/1990SE
K903767Ect (Emmission Computed Tomography) Carbon Fib PalIYZ · Traditional Siemens Gammasonics, Inc.09/07/1990SE

More from Siemens Gammasonics, Inc.

510(k)DeviceDecision
K952701Med-Tron SPECT Imaging TableIZZ · Traditional 07/06/1995SE
K911691Xyz Crank Imaging TableIYZ · Traditional 08/09/1991SE
K912135Xy Imaging TableIYZ · Traditional 07/17/1991SE
K911564E-Z Lift Imaging Table with Foot PumpIYZ · Traditional 07/15/1991SE
K911561Xyz Imaging Table with Foot PumpIYZ · Traditional 07/15/1991SE
K905827Full View Omega TableIYX · Traditional 01/28/1991SE
K903988Panoramic Omega Imaging TableIYX · Traditional 10/23/1990SE
K903901Scanning CotIYZ · Traditional 09/21/1990SE

Questions and answers

When was E-Z Lift Crank Imaging Table cleared by the FDA?

E-Z Lift Crank Imaging Table (K912181) received a 510(k) decision of Substantially Equivalent on July 17, 1991, 62 days after the submission was received.

What is the product code of K912181?

The FDA product code is IYZ – Bed, Scanning, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1350.