(94 days)
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No
The summary describes a mechanical auxiliary patient table and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
This device is an auxiliary patient table designed to support patients during MRI scans, rather than directly treating a medical condition or disease.
No
The device description states its purpose is to accommodate large, trauma, or claustrophobic patients and increase the magnet's vertical gap; it does not mention any functional use related to identifying, monitoring, or predicting diseases or conditions.
No
The device description clearly outlines physical components (base frame, extension frame, table plate) and its function as a physical support structure, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is an "auxiliary patient table" designed to support patients during Magnetic Resonance (MR) imaging. It's a physical support structure, not a device that analyzes biological samples.
- Intended Use: The intended use is to accommodate certain types of patients during MR scans by increasing the vertical gap of the magnet. This is a functional support role within the imaging process, not a diagnostic test performed on a sample.
The device is a piece of equipment used in conjunction with an imaging modality (MR) to facilitate the imaging process for specific patient populations. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The auxiliary patient table is designed to further accommodate large patients, trauma patients, claustrophobic patients, and those patients requiring monitoring. The new auxiliary table is designed to support up to 200kg (440 lbs) and is compatible with the commercially available CP Head and Multi-purpose Coils. This new system option is not intended as a transportation trolley.
Product codes
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Device Description
The auxiliary patient table docks into the standard OPEN table area and increases the vertical gap (ie. patient gap) of the magnet. The auxiliary patient table consists of a base frame, an extension frame, and a table plate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
SIEMENS
General Information.
I.
510 (k) Summary
MAR 2 9 1996
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- . Address: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830 Registration Number: . 2240869 ● Contact Person: Cathy Anne Pinto Sr. Technical Specialist, Regulatory Affairs (908) 321-4887 (908) 321-4841 December 22, 1995 ● Date of Summary Preparation: Proprietary Trade Name: . Auxiliary Patient Table/ MAGNETOM OPEN . Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000 . Classification: Class II None established under Section . Performance Standards: 514 of the Food, Drug, and Cosmetic Act.
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
· Device Description:
The auxiliary patient table docks into the standard OPEN table area and increases the vertical gap (ie. patient gap) of the magnet. The auxiliary patient table consists of a base frame, an extension frame, and a table plate.
Siemens Medical Systems, Inc.
maging Systems Group
1
SIEMENS
· Intended Use
The auxiliary patient table is designed to further accommodate large patients, trauma patients, claustrophobic patients, and those patients requiring monitoring. The new auxiliary table is designed to support up to 200kg (440 lbs) and is compatible with the commercially available CP Head and Multi-purpose Coils. This new system option is not intended as a transportation trolley.
· Technological Characteristics
There is no change to the magnet, rf system, and gradient system of the MAGNETOM OPEN by introduction of the auxiliary patient table.
• General Safety and Effectiveness Concerns:
Operation of the MAGNETOM OPEN system with the new auxiliary patient table is substantially equivalent to standard operation of the MAGNETOM OPEN system. The following safety parameter action levels:
- static field strength,
- -RF exposure,
and performance levels:
- signal-to-noise,
- high contrast spatial resolution. -
- slice thickness.
- image uniformity and, =
- geometric distortion.
specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.
• Substantial Equivalence:
The MAGNETOM OPEN with the new auxiliary patient table is substantially equivalent to standard operation of the MAGNETOM OPEN system.
Kathleen Rutherford
Kathleen M. Rutherfor Manager, Regulatory Submissions
12/22/95
Date