SMS 90-15 R&F Table and SMS 14 Spot Film Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K882019 ↗

FDA Product Code

IXR

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

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  Class II

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  Class II

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• What is the SMS 90-15 R&F Table and SMS 14 Spot Film Device used for?

  This device is a radiographic tilting table and spot film device designed to support patients during imaging examinations while allowing for precise positioning and film capture in radiology settings.

• How is the SMS 90-15 R&F Table and SMS 14 Spot Film Device supplied?

  The device is supplied by General Electric Co. and is manufactured in Milwaukee, Wisconsin. It includes various model numbers and is authorized under FDA 510K clearance with product code IXR.

• What is the regulatory status of the SMS 90-15 R&F Table and SMS 14 Spot Film Device?

  The device is authorized under FDA 510K clearance with product code IXR and is classified as a Class II medical device. It has multiple registration numbers and is intended for use in radiology settings.

• What are the specifications of the SMS 90-15 R&F Table and SMS 14 Spot Film Device?

  The device is a radiographic tilting table with spot film capabilities. It has been determined to be substantially equivalent and was reviewed by the Radiology advisory committee. The device includes various model numbers and has multiple FEI numbers and registration numbers associated with it.