(89 days)
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Not Found
No
The description focuses on conventional MRI techniques and image processing functions without mentioning AI or ML.
No
The device is described as an imager for producing cross-sectional images of internal structures, and its function relates to image generation and processing, not directly treating a disease or condition.
Yes
Explanation: The device is described as an "MR imager that produces...cross-sectional images of internal structures of the human body, head, and extremities." Imaging internal structures to visualize intrinsic properties of tissues is a diagnostic function, as it helps identify and characterize medical conditions.
No
The device description explicitly states it is a "proton (H-1) Magnetic Resonance Imaging device," which is a hardware-based imaging system, not software only.
Based on the provided information, the HI STAR system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "general purpose MR imager that produces transverse, sagittal, coronal, and oblique cross-sectional images of internal structures of the human body, head, and extremities." This describes an imaging device used to visualize internal anatomy, not a device used to examine specimens (like blood, urine, or tissue) outside of the body.
- Device Description: The description reinforces that it's a Magnetic Resonance Imaging (MRI) device that generates images of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The HI STAR system is an in vivo imaging device.
N/A
Intended Use / Indications for Use
The HI STAR system is indicated for use a general purpose MR imager that produces transverse, sagittal, coronal, and oblique cross-sectional images of internal structures of the human body, head, and extremities. Contrast in these images reflect the intrinsic oroperties of the hydrogen proton, proton density, T1, and T2, and the extrinsic parameters of the applied imaging sequences. The indications for the HI STAR do not differ significantly from the predicate, or legally marketed devices.
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
The Health Images HI STAR is a proton (H-1) Magnetic Resonance Imaging device. The HI STAR has been designed to produce transverse, sagittal, coronal, and oblique section images of the head, body and extremities of the human body. Contrast in these images is produced primarily by T1, T2, and proton density tissue characteristics. This imager employs conventional MRI imaging techniques in which the application of a combination of pulsed radio frequency energy and magnetic gradient fields is applied to the body to generate MR proton echo signals. These multidimensionally coded signals are converted by Fourier transform into 2D and 3D image sets.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, body, and extremities of the human body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Sample images included with this submission were obtained on R &D systems at Health Sample Includio war this oubmisers. Each volunteer signed a consent form. There were no adverse reactions noted on any of the participants.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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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FEB 2 4 1997
Attachment H
510 (k) Summary / Safety and Effectiveness
- 510 (k) Summary, Safety and Effectiveness
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The following information is in accordance with 21 CFR 807.92
Submitter's Name, Address, Telephone Number , Contact Person, Preparation Date
Health Images, Inc. 8601 Dunwoody Place Building 200 Atlanta, GA 30350 (770) 642-9869 ext. 2057 Richard Halbach, Dir. of Clinical Research & Regulatory Affairs
November 25, 1996
Name of the Device and Classification Name/Number
HI STAR, Magnetic Resonance Imager. The FDA has reclassified these devices, 90LNH, to Class II.
Predicate Devices
| Manufacturer | Commercial Name | Description |
|---|---|---|
| Health Images | HI-Standard | 0.6T whole body MRI imager, |
| superconducting magnet | ||
| Health Images | HI-Standard/Calibre | |
| IRIS sequence | 0.6T whole body MRI imager, | |
| superconducting magnet, IRIS | ||
| Silicone Specific Sequence | ||
| Health Images | HI STAR | 0.6T whole body MRI imager, |
| superconducting magnet | ||
| Elscint | Gyrex 2T Prestige | Spectral Fat Suppression, FSE |
| Philips | Gyroscan NT, 1T | Spectral Fat Suppression |
Description of the Device
The Health Images HI STAR is a proton (H-1) Magnetic Resonance Imaging device. The HI STAR has been designed to produce transverse, sagittal, coronal, and oblique section images of the head, body and extremities of the human body. Contrast in these images is produced primarily by T1, T2, and proton density tissue characteristics. This imager employs conventional MRI imaging techniques in which the application of a combination of pulsed radio frequency energy and magnetic gradient fields is applied to the body to generate MR proton echo signals. These multidimensionally coded signals are converted by Fourier transform into 2D and 3D image sets.
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194466
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Device Characteristics
| Parameter | Example |
|---|---|
| Type of magnet | Superconducting, |
| passive/active shim | |
| Static field strength | 0.6T |
| Type of RF coils | Transmit/Receive - quadrature |
| Body | |
| Receive - quadrature | |
| Head, MRA, Neck, | |
| Spine, Wrist | |
| Receive - linear | |
| Bilateral TMJ, Volume | |
| Extremity, Bilateral Breast, | |
| Shoulder | |
| General Purpose Surface | |
| (body & extremity) | |
| 29.2 cm x 15.2 cm | |
| (11.5 x 6.0 inch) | |
| 19.0 cm x 19.0 cm | |
| (7.5 x 7.5 inch) | |
| 12.7 cm x 12.7 cm | |
| (5.0 x 5.0 inch) | |
| 6.4 cm x 6.4 cm | |
| (2.5 x 2.5 inch) | |
| Data acquisition modes | Single slice, Multi-slice, Multi- |
| angle oblique, 3D Volume, | |
| Physiologic Gating | |
| Pulse Sequences | Spin Echo, Field Echo, Turbo |
| Field Echo, Multi-spin Echo, | |
| Inversion Recovery, MRA, FSE | |
| Additional Contrast Techniques | IRIS (Silicone Specific), FatSat, |
| Magnetization Transfer | |
| Reconstruction Technique | Fourier transform |
| Type of installation: | Mobile, Fixed |
| Slice selection method: | Selective Gradient, |
| 3D phase encode | |
| Display Matrix | Variable up to 1024 x 1024 |
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In plane 64 - 512, increment of Acquisition Matrix 8 2D, 1 - 256 slices, increment of Number of slices, 1 3D, 12 - 256 increment of 2 Range and Increment Window and level Post processing Rotate image Mirror image Zoom image Pan image Add and Subtract images HI-Q image processing noise reduction function Transverse, Sagittal, Coronal, Slice orientation Single and multiple oblique From Contiguous up to 320 mm, Interslice spacing, minimum, maximum, increment of 0.5 mm
....
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Intended Uses
The HI STAR system is indicated for use a general purpose MR imager that produces transverse, sagittal, coronal, and oblique cross-sectional images of internal structures of the human body, head, and extremities. Contrast in these images reflect the intrinsic oroperties of the hydrogen proton, proton density, T1, and T2, and the extrinsic parameters of the applied imaging sequences. The indications for the HI STAR do not differ significantly from the predicate, or legally marketed devices.
Safety Parameters
| Parameter | FDA Limit | HI STAR | Test Standard |
|---|---|---|---|
| Maximum Static Magnetic | |||
| Field | ≤ 2 tesla | 0.6T | Manufacturer |
| Rate of Magnetic Field | |||
| Strength change | ≤ 20 T/second |