(8 days)
No
The document describes a passive coil for receiving NMR signals in an MRI system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a diagnostic imaging coil used for visualizing parts of the human body, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the use of diagnostic imaging of the human body."
No
The device description clearly describes a physical coil with hardware components (phased array coil, PIN diodes, internal circuit board) used for receiving NMR signals, which is a hardware function.
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 (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The MJAH-137A Atlas SPEEDER Head/Cervical Coil is a component of an MRI system. It is used to receive signals from within the human body during a diagnostic imaging procedure. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "diagnostic imaging of the human body," "fluid visualization," "2D and 3D imaging," "MR angiography and MR fluoroscopy." These are all in-vivo (within the living body) diagnostic procedures.
Therefore, based on the provided information, this device is a component of an in-vivo diagnostic imaging system, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MJAH-137A Atlas SPEEDER Head/Cervical Coil is intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3, /S4 and Atlas Titan, model number MRT-1504.
Product codes
MOS
Device Description
The Atlas SPEEDER Head/cervical is a phased Array Coil that can receive NMR signal from head, cervical region and upper chest.
The coil is configured in three sections; a head base, a removable anterior coil, and NV chest coil. There are two types of anterior coil; 1) Head anterior coil for head imaging, and 2) Neck anterior coil for cervical imaging. The Neck anterior coil includes an adjustable NV coil which is combined with Head anterior coil.
During transmission by the QD body coil this coil is deactivated by means of PIN diodes located on the internal circuit board. Upon deactivation of the transmit cycle the coil switches on to the receive mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
head, cervical region and upper chest
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 in Appendix F & G.
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
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
KC) 3014
Appendix A
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Classification and Device Name 1.
Classification Name
Coil, magnetic resonance, specialty; 21 CFR 892.1000 [90-MOS]
Model Number
MJAH-137A
Trade/Propriety Name
Atlas SPEEDER Head/Cervical
2. Establishment Registration
2020563
U.S. Agent Name and Address 3.
Agent Name
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, CA 92780
Contact Person
Paul Biggins, Director Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310 pbiggins@tams.com
4. Manufacturing Site
Toshiba Medical Systems Corporation 1385 Shimoishiqami Otawara-shi, Tochigi-Ken Japan 324
Date of Submission 5.
September 30, 2008
Device Intended Use 6.
The MJAH-137A Atlas SPEEDER Head/Cervical Coil is intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3, /S4 and Atlas Titan, model number MRT-1504.
7. Device Description
The Atlas SPEEDER Head/cervical is a phased Array Coil that can receive NMR signal from head, cervical region and upper chest.
OCT 1 7 2008
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Appendix A
The coil is configured in three sections; a head base, a removable anterior coil, and NV chest coil. There are two types of anterior coil; 1) Head anterior coil for head imaging, and 2) Neck anterior coil for cervical imaging. The Neck anterior coil includes an adjustable NV coil which is combined with Head anterior coil.
During transmission by the QD body coil this coil is deactivated by means of PIN diodes located on the internal circuit board. Upon deactivation of the transmit cycle the coil switches on to the receive mode.
Safety Parameter 8.
Maximum static field strength
1.5 T
Maximum dB/dt
1st operation mode specified in IEC60601-2-33 (2005)
Maximum SAR
1st operation mode specified in IEC60601-2-33 (2005)
Peak and A-weighted Acoustic Noise Level
Not applicable
Biocompatibility
All materials used in contact with the patient will have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating.
9. Imaging Performance Parameter
Sample phantom images and clinical images are presented in Appendix F & G.
10. Equivalency Information
Toshiba Medical Systems Corporation believes that this Atlas SPEEDER Head/Cervical is substantially equivalent to the current Atlas SPEEDER Head [K063361] and SPEEDER 1.5T Wrist coil [K072935].
11. Software
There is no additional software required for this coil.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K083014
Trade/Device Name: Model MJAH-137A Atlas SPEEDER Head/Cervical COil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 8, 2008 Received: October 9, 2008
Dear Mr. Job:
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 such 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_
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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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
forque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K083014
Device Name: Model MJAH-137A Atlas SPEEDER Head/Cervical Coil
Indications for Use:
The MJAH-137A Atlas SPEEDER Head/Cervical Coil in intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR Fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3,S5 and the Atlas Titan, model number MRT-1504.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulda Reimer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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