(8 days)
No
The document describes standard MRI imaging techniques and software for image reconstruction and management. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
No.
The 'Intended Use' section explicitly states that the device is an "imaging device" used for "diagnosis determination" and to "produce images," not for treatment.
Yes
The device produces images that, when interpreted by a trained physician, "provide information that can be useful in determining a diagnosis." It is explicitly stated under "Diagnostic uses."
No
The device description explicitly states it is a "0.35T permanent magnet MRI system" and mentions the magnet is made of "NdFeB material," indicating it includes significant hardware components beyond just software.
Based on the provided information, the Superopen 0.35T is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Superopen 0.35T Function: The Superopen 0.35T is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structure of the body by utilizing magnetic fields and radio waves. This is a non-invasive imaging technique that does not involve the analysis of biological specimens.
- Intended Use: The intended use clearly states that it produces images that are interpreted by a trained physician to provide information useful in determining a diagnosis. This aligns with the function of an imaging device, not an IVD.
Therefore, the Superopen 0.35T falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Superopen 0.35T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial 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 diagnosis determination. Diffusion weighted imaging MR Angiography
The indications for use are as follows: Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses: Imaging capabilities: Imaging processing 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAIR) 2D.3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS) 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP MR Angiography 2D, 3D TOF MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion
Product codes
LNH
Device Description
The Superopen 0.35T is a 0.35T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
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
Image /page/0/Picture/0 description: The image shows the word "NEUSOFT" in a bold, sans-serif font. The letters are black, and the word is slightly slanted to the right. Above the word, there is a curved line made of small dots, which starts above the "N" and ends above the "T". The logo is simple and modern.
Attachment 1
APR 0 1 2003
Summary of Safety and Effectiveness
Page 1 of 2
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
General Information:
| Trade Name: | Superopen 0.35T |
|---|---|
| Model: | NSM-P035 (MRI System) |
| CFR Section: | 21 CFR Part 892.1000 |
| Magnetic resonance diagnostic device | |
| Classification Name: | System, Magnetic Resonance Imaging |
| Product Code: | LNH |
| Device Class: | Class II |
| Applicable Standard: | IEC60601-1, Medical electrical equipment - Part 1: General |
| Requirements for Safety | |
| IEC60601-2-33, Medical electrical equipment - Part 2-33: Particular | |
| requirements for the safety of magnetic resonance equipment for | |
| medical diagnosis | |
| 21 CFR Subchapter J, Radiological Health | |
| IEC60825-1, Safety of laser products-Part1:Equipment classification | |
| requirement and user's guide | |
| DICOM 3.0 | |
| NEMA MS Series (MS1 - MS8) | |
| Manufacture and | |
| Distributor: | NEUSOFT Digital Medical Systems Co., Ltd. |
| No.3-11, Wenhua Road, Heping District, | |
| Shenyang, China | |
| Post Code : 110004 | |
| Submitter: | Contact : Wang Zhiqiang |
| Title : Manager of Quality Management Department | |
| Tel : 86-24-83665003 | |
| Fax : 86-24-23782711 | |
| E-Mail : wangzq@neusoft.com | |
| Summary prepared : Mar. 14th, 2003 |
1
Image /page/1/Picture/0 description: The image shows the word "NEUSOFT" in a bold, sans-serif font. The word is slightly slanted to the right. Above the word, there is a dotted arc that starts from the left side of the "N" and curves over the word. The arc is made up of small dots that gradually decrease in size as they move to the right.
510(k)
Page 2 of 2
Safety and Effectiveness information
Intended Uses:
The Superopen 0.35T is intended to produce images that reflect the spatial 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.
Device Description:
The Superopen 0.35T is a 0.35T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
Predicated Device:
K974212 : AIRIS II (MRI System) K001334: AIRIS II Version 4.1 Software
Statement of Substantial Equivalence:
The Superopen 0.35T is of comparable type and substantially equivalent to the Hitachi AIRIS II (K974212) and the 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 MR Imaging System, use Gradient Subsystem to provide controlled and uniform gradient magnet fields in the X, Y and Z planes, and use RF Subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console' s computer 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 unit.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 1 2003
Neusoft Digital Medical Systems, Co. Ltd. % Mr. Heinz Joerg Steneberg TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K030918
Trade/Device Name: Superopen 0.35T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: March 20, 2003 Received: March 24, 2003
Dear Mr. Steneberg:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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.
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "NEUSOFT" in bold, sans-serif font. A curved line is above the word, starting from the left side of the "N" and ending above the "T". The text is black and the background is white.
Attachment 2 Page 2 of 2
Ko30 918 510(k) Number (if Known) Device Name: Superopen 0.35T Indications for use:
The Superopen 0.35T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial 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 diagnosis determination.
Diffusion weighted imaging
MR Angiography
The indications for use are as follows:
Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses:
Imaging capabilities:
Imaging processing 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAIR) 2D.3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS) 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP MR Angiography 2D, 3D TOF MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lessem
(Division Sign-Off) Division of Reproductive. A and Radiological Devices 510(k) Number
Prescription Use