(34 days)
Not Found
No
The document describes standard MRI technology and software for image processing and viewing, with no mention of AI or ML capabilities.
No
The "Intended Use / Indications for Use" section explicitly states that the system is a "diagnostic imaging device" used to produce images "useful in determining a diagnosis." It does not mention any therapeutic capability.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device".
No
The device description explicitly states it is a "0.4 Tesla permanent MRI system" and describes hardware components like the magnet. While it includes software, it is not solely software.
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 examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The i Open 0.4T system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body in vivo (within the living organism) using magnetic fields and radio waves. It does not analyze samples taken from the body.
- 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.
Therefore, the i Open 0.4T system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The i Open 0.4T 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 0.4T 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 (TI), 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
LNH
Device Description
The i Open 0.4T 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 0.4T 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 (TI), 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.
The i Open 0.4T is a 0.4 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.
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)
Reference Device(s)
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.
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 ad 21CFR 807.92.
l. 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
traditional Type of submission:
Device Name:
●Trade Name: i Open 0.4T
●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.
1
II. Safety and Effectiveness Information.
Device Description: .
See Part C document.
. Intended Use:
The i Open 0.4T 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 0.4T 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 (TI), 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 0.4T is a 0.4 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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K090433
Page 3 of 3
● Statement of Substantial Equivalence:
The i Open 0.4T 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 0.4T 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 Ficld
- . 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
specifical by the FDA guidance document for MR Diagnostic Devices that will be evaluated. The i Open 0.4T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IDC 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.
3
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 25th Street NW BUFFALO MN 55313
Re: K090433
Trade/Device Name: i_Open 0.4 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 11, 2009 Received: March 12, 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.
MAR 2.6 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppor/index.html.
Sincerely yours,
Janine M. Morris
anine 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): __ K0 90433
Device Name: i Open 0.4T
Indications for Use:
The i Open 0.4T 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 0.4T 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)
Prescription Use Yes (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K090433 |
|---|---|
| --------------- | --------- |