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K Number
K971307
Device Name
AMSCO SURGICAL TABLE
Manufacturer
STERIS Corporation
Date Cleared
1997-06-27

(80 days)

Product Code
FQO
Regulation Number
878.4960
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical table that provides flexible articulation and image amplification of the surgical patient.

Device Description

mobile, electro-hydraulically operated general surgical table

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is an FDA 510(k) clearance letter for a surgical table and does not contain information about the acceptance criteria, study data, or performance metrics of a device, especially not those related to an AI/ML powered device. It merely states that the device is substantially equivalent to a predicate device.

§ 878.4960 Operating tables and accessories and operating chairs and accessories.

(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.