(23 days)
Not Found
No
The document describes a patient table for radiographic systems and does not mention any AI or ML capabilities.
No
The device is described as a patient table used with radiographic systems for imaging purposes, not for treating conditions.
No
The device is described as a patient table used with radiographic systems for positioning patients during X-ray exposures; it does not perform any diagnostic function itself.
No
The device description clearly states it is a "floor mounted patient table" constructed of "carbon fiber material" and offered in two configurations, one of which is "motorized, adjustable height." This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "patient table used in conjunction with ... radiographic devices" for "radiographic exposures of the entire body". This describes a piece of equipment used to position a patient for imaging, not a device that performs tests on biological samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a "floor mounted patient table" constructed of carbon fiber, with options for motorized or fixed height. This aligns with the description of a physical support structure for a patient during an imaging procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, assays, or any other components typically associated with in vitro diagnostics.
Therefore, the Multix TOP / PRO Radiographic X-ray Table is a piece of medical equipment used in conjunction with radiographic imaging systems, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
90IZZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
entire body, specifically the skull, spinal column, chest and abdomen, as well as the extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K 971452
Image /page/0/Picture/1 description: The image contains the word "SIEMENS" in bold, black letters. The letters are large and take up most of the image. The font is sans-serif and the letters are evenly spaced. The background is white.
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:
1
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.