(14 days)
Not Found
No
The document describes a physical RF coil for MRI, not software or algorithms that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing algorithms, or performance metrics related to AI/ML.
No
This device is described as a receive-only phased array RF coil used to produce diagnostic images, not to treat any condition.
Yes
The device is explicitly stated to produce diagnostic images and is used for obtaining diagnostic images in Magnetic Resonance Imaging Systems.
No
The device description explicitly details physical hardware components (antenna arrays, rigid and flexible housing, hook and loop straps) that are integral to its function as an RF coil for MRI. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The NeoCoil 3.0T 32-Channel Torso Array Coil is a component of a Magnetic Resonance Imaging (MRI) system. It's a receive-only RF coil used to acquire signals from the patient's body during an MRI scan.
- Intended Use: The intended use is to produce diagnostic images of the chest, abdomen, and pelvic area in vivo (within the living body).
- No mention of samples: The description and intended use do not involve testing any samples taken from the body.
Therefore, the NeoCoil 3.0T 32-Channel Torso Array Coil is a medical device used for in vivo imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The NeoCoil 3.0T 32-Channel Torso Array Coil is a receive only phased array RF coil used to produce diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging systems that can be interpreted by a trained physician. The NeoCoil 3.0T 32-Channel Torso Array Coil is designed for use with the 3.0T HD Series MR System manufactured by General Electric Healthcare (GEHC).
Indications for Use: The NeoCoil 3.0T 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.0T GE HD series Magnetic Resonance scanners.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The NeoCoil 3.0T 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE 3.0T HD Series MR System (K052293)
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
chest, abdomen, pelvic area, torso
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to demonstrate to that the design of the NeoCoil 3.0T 32-Channel Torso Array Coil met predetermined acceptance criteria.
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.
GE 3.0T Torso Phased Array Coil (K030495), GE 1.5T 8 Channel Torso Coil (K031209)
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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510(k) Summary
| Proprietary Name: | NeoCoil 3.0T 32-Channel Torso Array Coil |
|---|---|
| Common Device Name: | Magnetic Resonance Specialty Coil |
| Regulation Number: | 892.1000 |
| Review Panel: | Radiology Device Panel |
| CDRH Product Code: | MOS |
| Device Class: | II |
| Reason for 510(k): | New device |
| Applicant: | NeoCoil |
| N27 W23910A Paul Rd | |
| Pewaukee, WI 53072 | |
| Contact | Brian Brown |
| Executive Director | |
| 262-347-1250 x 12 (office) | |
| 261-347-1251 (fax) | |
| brian.brown@neocoil.com | |
| Preparation date: | 04/02/2007 |
| Est. Registration No: |
NOV 3 0 2007
| Intended Use: | The NeoCoil 3.0T 32-Channel Torso Array Coil is a receive only phased array RF coil used to produce diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging systems that can be interpreted by a trained physician. The NeoCoil 3.0T 32-Channel Torso Array Coil is designed for use with the 3.0T HD Series MR System manufactured by General Electric Healthcare (GEHC). |
|---|---|
| Indications for Use | The NeoCoil 3.0T 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.0T GE HD series Magnetic Resonance scanners. |
| Performance Standards: | No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act. |
| Device Description: | The NeoCoil 3.0T 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE 3.0T HD Series MR System (K052293) |
| Predicate Devices: | GE 3.0T Torso Phased Array Coil (K030495) GE 1.5T 8 Channel Torso Coil (K031209) |
| Comparison to Predicate: | The NeoCoil 3.0T 32-Channel Torso Array Coil is most similar to the GE 1.5T 8 Channel Torso Coil (K031209) with the main differences being the number of elements and the field strength. The NeoCoil Torso Coil uses 34 |
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elements compared to 12. It also operates at 3.0T like the GE 3.0T Torso Phased Array Coil (K030495) instead of 1.5T. Testing was performed to demonstrate to that the design of the NeoCoil 3.0T Summary of Studies: 32-Channel Torso Array Coil met predetermined acceptance criteria. It is the opinion of NeoCoil that the NeoCoil 3.0T 32-Channel Torso Array Conclusion:
Coil is substantially equivalent to the predicate devices. Use of the NeoCoil 3.0T 32-Channel Torso Array Coil does not result in any new potential hazards and does not alter the safety of the MRI scanner.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2007
NeoCoil % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K073236
Trade/Device Name: NeoCoil 3.0T 32-Channel Torso Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 15, 2007 Received: November 16, 2007
Dear Mr. Lehtonen
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 ean 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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 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
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Indications for Use
K073236 510(k) Number (if known): __
Device Name: NeoCoil 3.0T 32-Channel Torso Array Coil
Indications For Use:
The NeoCoil 3.0T 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.0T GE HD series Magnetic Resonance scanners.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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lomikhing
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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