← Product Code [LNH](/productcode/LNH) · K964778 # HI-STAR MRI IMAGING SYSTEM (K964778) _Health Images, Inc. · LNH · Feb 24, 1997 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K964778 ## Device Facts - **Applicant:** Health Images, Inc. - **Product Code:** [LNH](/productcode/LNH.md) - **Decision Date:** Feb 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The HI STAR system is indicated for use as 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 properties 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. ## Device Story HI STAR is a 0.6T superconducting whole-body MRI system. It uses pulsed radio frequency energy and magnetic gradient fields to generate proton echo signals from human tissue. Signals are converted via Fourier transform into 2D/3D images. Operated by trained personnel in fixed or mobile clinical settings. Includes various RF coils (body, head, extremity, surface) for specific anatomical coverage. Supports multiple pulse sequences (Spin Echo, FSE, MRA, IRIS, FatSat). Post-processing includes window/level, rotation, zoom, pan, and HI-Q noise reduction. Output images assist clinicians in diagnostic assessment of internal structures. Benefits include non-invasive visualization of anatomy without ionizing radiation. ## Clinical Evidence Bench testing only. Performance validated against NEMA and AAPM standards for signal-to-noise ratio, image uniformity, slice thickness, resolution, and geometric distortion. Safety parameters (static field, SAR, acoustic noise) verified against IEC 601-2-33 and NEMA MS-4. Sample images obtained from employee volunteers to demonstrate image quality; no adverse reactions reported. ## Technological Characteristics 0.6T superconducting magnet with passive/active shimming. Quadrature transmit/receive body coils and various receive-only surface coils. Pulse sequences: Spin Echo, Field Echo, Turbo Field Echo, Multi-spin Echo, Inversion Recovery, MRA, FSE, IRIS, FatSat, Magnetization Transfer. Reconstruction via Fourier transform. Installation: fixed or mobile. Connectivity: variable display matrix up to 1024x1024. Standards: IEC 601-2-33, NEMA MS-1, MS-2, MS-4, MS-6, AAPM-28. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - HI-Standard ([K964778](/device/K964778.md)) - HI-Standard/Calibre IRIS sequence ([K964778](/device/K964778.md)) - HI STAR ([K964778](/device/K964778.md)) - Gyrex 2T Prestige (Elscint) - Gyroscan NT, 1T (Philips) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K964778 FEB 24 1997 # Attachment H ## 510 (k) Summary / Safety and Effectiveness 1. 510 (k) Summary, Safety and Effectiveness {1} 510 (k) Summary, Safety and Effectiveness Health Images HI STAR MRI Device 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 boy 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. {2} 510 (k) Summary, Safety and Effectiveness Health Images HI STAR MRI Device ## 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 | {3} 510 (k) Summary, Safety and Effectiveness Health Images HI STAR MRI Device | Acquisition Matrix | In plane 64 - 512, increment of 8 | | --- | --- | | Number of slices, | 2D, 1 - 256 slices, increment of 1 | | Range and Increment | 3D, 12 - 256 increment of 2 | | Post processing | Window and level Rotate image Mirror image Zoom image Pan image Add and Subtract images HI-Q image processing noise reduction function | | Slice orientation | Transverse, Sagittal, Coronal, Single and multiple oblique | | Interslice spacing, minimum, maximum, | From Contiguous up to 320 mm, increment of 0.5 mm | {4} 510 (k) Summary, Safety and Effectiveness Health Images HI STAR MRI Device # Intended Uses The HI STAR system is indicated for use as 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 properties 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 | < 20 T/s | IEC 601-2-33 | | SAR | < 1.5 W/kg, averaged over whole body (First Controlled Operating Level) | < 1.5 W/kg | IEC 601-2-33 | | | 1.5 ≤ SAR < 4.0 W/kg, averaged over whole body (Second Controlled Operating Level) | 1.5 ≤ SAR < 4.0 W/kg | IEC 601-2-33 | | Acoustic Noise Levels | < 105 dB (A weighted average over 1 hour) | < 92 dBA | NEMA MS-4 | ## Imaging Performance Parameters | Parameter | Data | Standard | | --- | --- | --- | | Specification Volume | Head 25.6 cm DSV Body 48 cm DSV | Manufacturer | | Signal-to-noise Ratio | | | | Body Coil | 103 | NEMA MS-1 | | Head Coil | 62 | NEMA MS-1 | | MRA Coil | 50 | NEMA MS-6 | | Wrist Coil | 117 | NEMA MS-6 | | Neck Coil | 108 | NEMA MS-6 | | Spine Coil | 62 | NEMA MS-6 | | Breast Coil | 100 | NEMA MS-6 | | Bilateral TMJ Coil | 133 | NEMA MS-6 | | Extremity Coil | 49 | NEMA MS-6 | | Shoulder Coil | 108 | NEMA MS-6 | {5} 510 (k) Summary, Safety and Effectiveness Health Images HI STAR MRI Device | Parameter | Data | Standard | | --- | --- | --- | | General Purpose Surface Coils | | NEMA MS-6 | | 29.2 cm x 15.2 cm (11.5 x 6.0 inch) | 95 | | | 19.0 cm x 19.0 cm (7.5 x 7.5 inch) | 98 | | | 12.7 cm x 12.7 cm (5.0 x 5.0 inch) | 80 | | | 6.4 cm x 6.4 cm (2.5 x 2.5 inch) | 133 | | | Image Uniformity Body Coil | 12%, Specification Volume 48 cm NEMA MS-2 | | | Head Coil | 6%, Specification Volume 25.6 cm NEMA MS-2 | | | Slice Thickness, Separation | 10% of specified | AAPM-28 | | Resolution | Body 1.5 mm Head 1 mm AAPM-28 | | | Geometric Distortion | Body < 5% @ 31 cm Head < 5% @ 15.5 cm | NEMA #2 | Sample images included with this submission were obtained on R &D systems at Health Images, Inc. using employee volunteers. Each volunteer signed a consent form. There were no adverse reactions noted on any of the participants. --- **Source:** [https://fda-staging.innolitics.com/device/K964778](https://fda-staging.innolitics.com/device/K964778) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com