MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
K971452 · Siemens Medical Solutions USA, Inc. · IZZ · May 14, 1997 · Radiology
Device Facts
| Record ID | K971452 |
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| Device Name | MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE |
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| Applicant | Siemens Medical Solutions USA, Inc. |
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| Product Code | IZZ · Radiology |
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| Decision Date | May 14, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 892.1980 |
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| Device Class | Class 2 |
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Intended 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.
Device Story
Floor-mounted, free-floating patient table; carbon fiber construction. Used as integral component of Siemens Multix TOP and PRO radiographic systems. Available in motorized adjustable-height or fixed-height (PRO FIX) configurations. Supports patient positioning (sitting, standing, prone) for X-ray exposures of skull, spine, chest, abdomen, and extremities. Operated by radiology staff in clinical imaging environments. Facilitates patient alignment for diagnostic imaging; enables radiographic system functionality.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Floor-mounted, free-floating patient table; carbon fiber material. Configurations: motorized adjustable-height or fixed-height. Integral component of radiographic system including X-ray generator, tube support, collimator, and Bucky wall stand. No software or electronic sensing described.
Indications for Use
Indicated for patients requiring radiographic imaging of the skull, spinal column, chest, abdomen, and extremities. Supports sitting, standing, or prone positioning.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Multix U/C (K803130)
- Compax 40E (K884930)
Related Devices
- K973039 — LEGACY/LEGACY-D TABLE · GE Medical Systems · Oct 16, 1997
- K973842 — CARBON FIBER CONFORMAL COUCH TOP · Medtec, Inc. · Dec 5, 1997
- K121513 — MULTIX FUSION · Siemens Medical Solution · Aug 10, 2012
- K981227 — SYMPHONY 360 REMOTE CONTROL TABLE · Acoma Medical Imaging, Inc. · Jun 30, 1998
- K993665 — LEGEND CRF FLUORO AND RAD SYSTEM · Ge Medical Systems, Inc. · Nov 12, 1999
Submission Summary (Full Text)
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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:
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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.
