(84 days)
No
The document describes a passive RF coil for MRI and does not mention any AI or ML components or functionalities.
No.
The device is used for obtaining diagnostic images. It does not perform any therapeutic function like treating, curing, or preventing diseases.
Yes
The device is used to obtain diagnostic images, and these images, when interpreted by a trained physician, yield information useful for diagnosis.
No
The device is described as a "receive-only phased array RF coil" with physical components like "elements and associated circuitry are enclosed in a housing made of plastic materials." This clearly indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- This device is an RF coil used in Magnetic Resonance Imaging (MRI). MRI is an in vivo (within the body) imaging technique that uses magnetic fields and radio waves to create images of the internal structures of the body.
- The intended use clearly states it's for obtaining diagnostic images of the abdomen, pelvis, and lumbar spine regions in Magnetic Resonance Imaging Systems. This is a direct interaction with the patient's body, not a test performed on a sample outside the body.
Therefore, the Body Array Coil is a component of an MRI system, which is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Body Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the abdomen, pelvis and lumbar spine regions in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI by Siemens Medical scanner manufactured Systems, Inc.
The Body Array Coil is designed to provide Magnetic Resonance Images of the torso region including the abdomen, thoracic, and lumbar spine anatomy. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla scanner.
Anatomic Regions: Torso, Abdomen and Spine Anatomy Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody 1.0Tesla system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes
90 MOS
Device Description
The Body Array Coil is a four-element receive-only phased array RF coil. The coil consists of two sections: upper and lower sections, which are positioned above and below the patient torso respectively. The upper section is latched on to the former bottom during imaging. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have a high impact and tensile strength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
abdomen, pelvis and lumbar spine regions, torso, abdomen, thoracic, and lumbar spine anatomy, head and whole body.
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)
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
JAN 2 2 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
Body Array Coil
Class II
K013594
page 1 of 2
- Device Name:
Magnetic Resonance Imaging Accessory
-
Proprietary Name:
-
Classification:
-
Establishment Registration #:
-
Manufacture Facility Location:
-
Performance Standard:
-
Intended Use:
-
Device Description:
1529041 USA Instruments, Inc., 1515 Danner Drive Aurora, Ohio 44202, USA
Telephone: 330-562-1000; Fax: 330-562-1422.
No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
The Body Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the abdomen, pelvis and lumbar spine regions in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI by Siemens Medical scanner manufactured Systems, Inc.
The Body Array Coil is a four-element receive-only phased array RF coil. The coil consists of two sections: upper and lower sections, which are positioned above and below the patient torso respectively. The upper section is latched on to the former bottom during imaging. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have a high impact and tensile strength.
1
9. Safety and Effectiveness
| Body Array Coil
Product Features | Comparison to Predicate or other 510(k) cleared
products |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Torso Imaging including abdomen,
chest, lumbar and thoracic spine | -Similar to Insight Plus 9000 Torso and Pelvis Coil
manufactured by USA Instruments, Inc. (K001209)
-Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482) |
| Indications for Use
Identical to routine MRI imaging | -Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482) |
| Coil Material
Royalite R59™ ABS Plastic
Polyurethane | -Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482) |
| Coil Design
Receive-only phased array design | -Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482) |
| Decoupling
RF Chokes with Switching Diodes | -Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482)
-Similar to Insight Plus 9000 Torso and Pelvis Coil
manufactured by USA Instruments, Inc. (K001209) |
| Prevention of RF Burns
Does not transmit RF Power,
Decoupling isolates the coil elements
from RF fields during RF transmission,
Coil elements and circuitry
are enclosed in a non-conductive
housing. | -Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482) |
| Radio Frequency Absorption
Coil is a receive only coil and does not
transmit RF power | -Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482) |
| Formation of Resonant Loops
Decoupling isolates coil elements from
RF fields during RF transmission,
Length of cable and stiffness does not
permit looping | -Similar to Vision 5000 Phased Array Torso Coil
manufactured by USA Instruments, Inc. (K002482) |
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Mr. Rony Thomas Vice President, Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K013594 Trade/Device Name: Body Array Coil MRI Specialty Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 31, 2001 Received: October 30, 2001
Dear Mr. Thomas:
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. Iisting 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 (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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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/dsmaldsmamain.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
510(k) Number (if known):__K 01 35 94
Device Name: Body Array Coil
Indications for Use: The Body Array Coil is designed to provide Magnetic Resonance Images of the torso region including the abdomen, thoracic, and lumbar spine anatomy. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla scanner.
Anatomic Regions: Torso, Abdomen and Spine Anatomy Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody 1.0Tesla system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
|------------------------------------------------------------------|----------------------------------------------------|----|--------------------------------------------------|
| (Division Sign-Off) | Tanya Brighton | | |
| Division of Reproductive, Abdominal,
and Radiological Devices | | | |
| 510(k) Number | K013594 | | |