(23 days)
The Multix TOP / PRO Radiographic X-ray Table is a patient table used in conjunction with the Siemens Multix PRO - and TOP Systems * radiographic devices. The table allows for radiographic exposures of the entire body, specifically the skull, spinal column, chest and abdomen, as well as the extremities. Applications can be performed with sitting, standing or prone patient positioning.
The Multix TOP / PRO Radiographic X-ray Table is a floor mounted patient table that is free-floating and constructed of carbon fiber material. The patient table is offered in two configurations and is a slightly modified, upgraded version of the original Multix U/C. One configuration is the motorized, adjustable height patient table which is used in the Multix TOP and PRO Systems. The other configuration (PRO FIX) is the fixed height patient table which is used in the Multix PRO Systems.
This document, K971452, for the "Multix TOP/ PRO Radiographic X-ray Table," is a 510(k) summary submitted to the FDA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it's an X-ray table, not a device with performance metrics requiring such a study in the context of AI or diagnostic accuracy.
Therefore, I cannot provide the requested information for the following reasons:
- Device Type: The device is a radiographic X-ray table, which is a piece of medical imaging hardware. Its primary function is to position patients for X-ray examinations.
- Nature of 510(k) Submission: A 510(k) submission for this type of device typically focuses on substantial equivalence to predicate devices based on design, materials, intended use, and general safety and effectiveness. It does not involve performance studies related to accuracy, sensitivity, or specificity in the way AI or diagnostic devices do.
- Lack of Performance Claims: There are no performance claims related to diagnostic accuracy or interpretation that would necessitate acceptance criteria, a test set, ground truth, or an MRMC study.
The document discusses:
- Its intended use (patient positioning for X-ray exposures).
- Substantial equivalence to existing predicate devices (other X-ray tables).
- Technological characteristics (floor-mounted, free-floating, carbon fiber, motorized/fixed height).
In summary, the provided text does not contain the information needed to answer your request, as it pertains to a different type of medical device and regulatory submission context.
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K 971452
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Attachment 12
MAY 1 4 1997
510(k) Summary
Multix TOP/ PRO Radiographic X-ray Table
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830 Establishment Registration Number: 2240869
April 16, 1997
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
Contact Person: 1.
Jeffrey W. Koontz Phone: (908) 321-8830 Fax: (908) 321-4841
Device Name and Classification: 2.
Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Device Code:
Multix TOP/PRO Radiographic X-ray Table Radiologic Table Radiology 21 CFR §892.1980 Class II 90IZZ
Intended Use: 3.
The Multix TOP / PRO Radiographic X-ray Table is a patient table used in conjunction with the Siemens Multix PRO - and TOP Systems * radiographic devices. The table allows for radiographic exposures of the entire body, specifically the skull, spinal column, chest and abdomen, as well as the extremities. Applications can be performed with sitting, standing or prone patient positioning.
Substantial Equivalence: 4.
The Multix TOP / PRO Radiographic X-ray Table is substantially equivalent to the following devices in commercial distribution:
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SIEMENS
- Multix U/C, K803130 . Siemens Medical Systems, Inc.
- . Compax 40E*, K884930 General Electric Co.
- Please note, it is believed the GE Compax 40E is described in the 半 FDA Clearance for the GE Compax 40 under 510(k) K884930.
- Device Description: 5.
The Multix TOP / PRO Radiographic X-ray Table is a floor mounted patient table that is free-floating and constructed of carbon fiber material. The patient table is offered in two configurations and is a slightly modified, upgraded version of the original Multix U/C. One configuration is the motorized, adjustable height patient table which is used in the Multix TOP and PRO Systems. The other configuration (PRO FIX) is the fixed height patient table which is used in the Multix PRO Systems.
- Summary of Technological Characteristics of the Device Compared to 6. the Predicate Devices:
The Multix TOP / PRO Radiographic X-ray Table has the same technological characteristics as the predicate Siemens Multix U/C Table and GE Compax 40E Table. The table is not a stand alone device but is an integral part of an overall radiographic system. All systems contain the same basic configurations with the following standard components: X-ray table, cassette holders, tube supports, X-ray tubes, collimator, Bucky wall stand and X-ray generator.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.