(81 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on software modifications and new sequences for image acquisition and reconstruction.
No
The device is described as software that facilitates the acquisition and reconstruction of MR images for diagnostic imaging purposes, not for treating any condition.
Yes
The device is described as facilitating the acquisition and reconstruction of MR images for imaging various parts of the human body, which is a fundamental aspect of diagnostic imaging for medical professionals.
No
The device description explicitly states it is "software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images." This indicates it is software that facilitates the function of an MR imaging system, which is a hardware device. It is not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as "Imaging of: The Whole Body..." and lists various imaging applications. This is consistent with a medical imaging device used for visualizing internal structures of the body.
- Device Description: The description focuses on software modifications and new sequences for acquiring and reconstructing MR images. This is also characteristic of an imaging system.
- Input Imaging Modality: The input modality is "Magnetic Resonance," which is an imaging technique, not a method for analyzing biological samples in vitro.
- Anatomical Site: The anatomical site is the "Whole Body," indicating it's used on a living patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the body) to examine these samples.
Therefore, this device is a medical imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Diagnostic imaging of the human body (including head, abdomen, breast, heart, pelvis, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
Imaging of:
The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynavic Scan and Cine Imaging.]
- Fluid Visualization
- 2D/3D Imaging
- MR Angiography/MR Vascular Imaging -
Product codes
90 LNH
Device Description
Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images.
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, body, extremity, spine, neck, TMJ, breast, and heart
Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Sample phantom images and clinical images are presented for new sequences.
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) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
2636923
Bruce Clark
-
- DEVICE NAME: Model Number: Trade/Proprietary Name:
Magnetic Resonance Diagnostic Device Accessory MRT-600 OPART™
- DEVICE NAME: Model Number: Trade/Proprietary Name:
ESTABLISHMENT REGISTRATION: 2.
- U.S. AGENT NAME AND ADDRESS: 3.
CONTACT PERSON:
MANUFACTURING SITE: 4.
-
- DATE OF SUBMISSION:
- DEVICE DESCRIPTION: (650)872-2722 ext. 6068
280 Utah Avenue
Toshiba America MRI, Inc.
Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080
South San Francisco, CA 94080
April 20, 1998
Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images.
0.35 Tesla
7.
SAFETY PARAMETERS: Maximum static field strength:
Rate of change of magnetic field: 19T/second Maximum radio frequency power deposition (SAR): TM (MRT-600) Versions 2 Software Upgrade |
| Indications for Use: | (unchaged from initial OPART TM system K962933) |
| Imaging of: | |
The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynavic Scan and Cine Imaging.]
- -Fluid Visualization
- ・ 2D/3D Imaging
- MR Angiography/MR Vascular Imaging -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K981475 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR§801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-96)CONFIDENTIAL