(14 days)
Not Found
No
The summary describes a standard MRI system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic performance evaluation.
No.
The device is described as an imaging system used for diagnosis, not for treating any condition.
Yes
The text explicitly states: "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." and lists "Diagnostic uses" within its indications for use.
No
The device description explicitly states it is a "0.23T permanent magnet MRI system," which is a hardware component. While it includes software, it is not solely 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Superopen 0.23T is an imaging device that uses Magnetic Resonance Imaging (MRI) to create images of the internal structure of the body. It obtains information non-invasively and without using specimens from the body.
- Intended Use: The intended use clearly states it provides physiological and clinical information obtained non-invasively.
- Input: The input is MRI, which is an imaging modality, not a biological specimen.
Therefore, based on the provided information, the Superopen 0.23T falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Superopen 0.23T 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.
The Superopen 0.23T 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.
The indications for use are as follows:
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging, MR Angiography, Imaging processing
Imaging capabilities: 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
Product codes (comma separated list FDA assigned to the subject device)
LNH, 90 LNH
Device Description
The Superopen 0.23T is a 0.23T 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): 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.
0
Image /page/0/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 "S". The word is in all caps and appears to be a logo or brand name.
Attachment 1
KO 33315
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 0.23T |
|---|---|
| Model: | NAM-P023A (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, P.R.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 : July 16th, 2003 |
1
Image /page/1/Picture/0 description: The image shows the word "NEUSOFT" in bold, sans-serif font. A curved line is above the word. The word is in all caps and is black.
510(k)
Page 2 of 2
Safety and Effectiveness information
Intended Uses:
The Superopen 0.23T 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 0.23T is a 0.23T 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:
K030918 : Superopen 0.35T (MRI System)
Statement of Substantial Equivalence:
The Superopen 0.23T is of comparable type and substantially equivalent to the NEUSOFT Superopen 0.35T (K030918) 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
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Neusoft Digital Medical Systems Co., Ltd. % Mr. Heinz-Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K033315
Trade/Device Name: Superopen 0.23T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: October 13, 2003
Received: October 15, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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
4
NEUSOFT
510(k)
Attachment 2 Page 2 of 2
KO333315 510(k) Number (if Known) Device Name: Superopen 0.23T Indications for use:
The Superopen 0.23T 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.
The indications for use are as follows:
| Anatomical Region: | Head, Body, Spine, Extremities |
|---|---|
| Nucleus excited: | Proton |
| Diagnostic uses: | T1, T2, proton density weighted imaging |
| MR Angiography | |
| Imaging processing | |
| Imaging capabilities: | 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 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
David A. Seaman
(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number