(10 days)
Not Found
No
The document describes standard MRI system components and software for image reconstruction and processing, with no mention of AI or ML.
No
The device is described as a "diagnostic imaging device" that produces images to help in "determining a diagnosis," not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic imaging device... When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis."
No
The device description explicitly states it is a "0.5 Tesla permanent MRI system" and mentions the magnet material, indicating it includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The i Open 0.5T system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body without taking any specimens. It uses magnetic fields and radio waves to create these images.
- Intended Use: The intended use clearly states it's a "diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities." This is consistent with an imaging device, not an IVD.
The information provided describes a standard medical imaging device used for diagnostic purposes based on visualizing internal anatomy, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The i Open 0.5T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the i Open 0.5T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
See Part C document.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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.
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Page 1 of 3
510(k) Summary
APR 1 0 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 ad 21CFR 807.92.
I. General Information
Establishment:
| Name: | Beijing Wandong Medical Equipment Co., Ltd |
|---|---|
| Address: | No.7, SanJianFang NanLi, ChaoYang District, |
| Beijing, CHINA, 100024 | |
| Phone: | +86 10 84575844 |
| Fax: | +86 10 84575842 |
Registration Number: 3004859018
| Contact Person: | Mr. Wang Weimin
Manager, | |
|-----------------|-----------------------------|-----------------|
| | Phone: | +86 10 84575844 |
| | Fax: | +86 10 84575842 |
| | E_Mail: | wmw@263.net.cn |
Date of Summary Preparation: Dec 17, 2008
Type of submission: traditional
Device Name:
- ●Trade Name: i Open 0.5T
●Classification Number:
Magnetic Resonance Diagnostic Device, CFR 892.1000 90-LNH
- ●Classification: Class II
●Performance Standards:
None established under Section 514 the Food, Drug, and Cosmetic Act.
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II. Safety and Effectiveness Information.
. Device Description:
See Part C document.
● Intended Use:
The i_Open 0.5T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the i Open 0.5T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
| Anatomical Region: | Head, Body, Spine, Extremities |
|---|---|
| Nucleus excited: | Proton |
| Diagnostic uses: | T1,T2 weighted |
| Proton density weighted | |
| MIP-MRA | |
| Water suppress imaging | |
| fat suppress imaging | |
| MRCP | |
| Imaging capabilities: | 2D Spin Echo (SE) |
| 2D,3D Fast Spin Echo(FSE) | |
| 2D Short Tau Inversion Recovery (STIR) | |
| 2D Fluid Attenuated Inversion Recovery (FLAIR) | |
| 2D,3D Rewinded Gradient Echo (2D, 3D Rewinded-GRE) | |
| 2D, 3D Spoiled Gradient Echo (2D,3D Spoiled-GRE) | |
| 2D,3D Time of Flight Angiography (TOF) |
. Technological Characteristics (comparison with predicate device):
The i_Open 0.5T is a 0.5 Tesla permanent MRI system. The magnet is mainly made of Nd-B-Fe material. The system software based on Windows XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing.
● Predicated Device:
K974212: Hitachi AIRIS II K001334: AIRIS II Version 4.1 Software
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K090873
page 3 of 3
. Statement of Substantial Equivalence:
The i Open 0.5T is of comparable type and substantially equivalent to Hitachi AIRIS II (K974212) and AIRIS II version 4.1 Software (K001334) in that they are similar in technology and intended uses. Both of these systems are open-permanent-magnet MRI Imaging System, use Gradient Subsystem to provide controlled and uniform gradient magnet fields in the X, Y and Z directions, and use RF Subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console that has an interactive user interface, and the system produces 2D and 3D image that can be filmed or electronically stored for future review. Both of these systems have the traditional MRI units.
. General Safety and Effectiveness Concerns:
Operation of the i_Open 0.5T is substantially equivalent to the commercially available AIRIS II. The following are the safety parameter with action levels:
- . Maximum Static Field
- Rate of Change of Magnetic Field .
- RF Power Deposition .
- Acoustic Noise Levels
and performance levels:
- Specification Volume .
- Signal to Noise
- Image Uniformity
- . Geometric Distortion
- Slice Profile, Thickness and Gap
- High Contrast Spatial Resolution
specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated. The i Open 0.5T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to currently available system.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
APR 1 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Beijing Wandong Medical Equipment Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street NW BUFFALO MN 55313
Re: K090873 .
Trade/Device Name: i_Open 0.5 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 30, 2009 Received: March 31, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _