(44 days)
K 012491, K 063313, K 993477, K 963356, K 010074, K 071882
Not Found
No
The document describes an MRI coil and its intended use for diagnostic imaging. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a "diagnostic imaging device" used to produce images for "determining diagnosis," not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for diagnostic" use and "indicated for use as a diagnostic imaging device".
No
The device description clearly states it is a "multifunctional coil" and describes physical components like "2x4-channel phased array receive only coils," "plugs," and a "base plate." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Noras CPC is a coil used in conjunction with an MRI scanner to produce images of internal body structures. It is a component of an imaging system, not a device that analyzes biological specimens.
- Intended Use: The intended use is for "Body-imaging for diagnostic with a MRI system" and to "produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body." This is clearly an in-vivo imaging application, not an in-vitro diagnostic test.
Therefore, the Noras CPC falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system.
It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body When ınterpreted by a trained physician, these images provide information that can be use in determining diagnosis.
The application area shouldn't be bigger than 20 cm because of the depth of 10 om per coll The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with sumilar structure can be taken.
Product codes (comma separated list FDA assigned to the subject device)
90MOS, LNH
Device Description
The CPC is a multifuntional coil for 1 5T and 3T MRI-systems, with 2x4-channel phased array receive only colls The coils are pre-tuned in the fixed load and no further tuning or matching is required for the user.
The coll is divided into two spherical parts Each half contains a 4 channel receive only array The coils were used together with a parallel imaging procedure.
Each coll has its own plug The plug is specific to the MRI-system and can't be mixed up with a not designated MRI-system.
The base plate is flat and is suitable on each Siemens MRI-system table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with similar structure
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): 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.
K 012491, K 063313, K 993477, K 963356, K 010074, K 071882
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.
0
Image /page/0/Picture/0 description: The image shows the text "KO83578" in a handwritten-like font. Below this, the text "Section 9 510(k) summary" is printed in a standard font. The text appears to be part of a document or label.
CPC Multipurpose Coil
Date of Summary Preparation: November 20, 2008
JAN 1 6 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
- General Information
Importer/Distributor
Name and Address Noras MRI products GmbH Leibnizstrasse 4 97204 Höchberg Germany
Establishment Registration Number 3004929307
Manufacturing Site
Name and Address
Noras MRI products GmbH
Leıbnızstrasse 4
97204 Höchberg
Germany
Establishment Registration Number 3004929307
Owner/Operator 9071737
1
2. Contact Person
Zahed Sedighiani Noras MRI products GmbH Leibnizstr 4 97204 Höchberg, Germany Telephone: (+49) 931/29927-17 Fax: (+49) 931/29927-20 Email Address: zahed sedightanı@noras de
3. Device Name and Classification
| Trade Name: | Noras CPC - Multifunctional Coil |
|---|---|
| Common Name: | CPC |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR § 892 1000 |
| Device Class: | II |
| Product Code: | 90MOS and LNH |
4. Device Description
1
The CPC is a multifuntional coil for 1 5T and 3T MRI-systems, with 2x4-channel phased array receive only colls The coils are pre-tuned in the fixed load and no further tuning or matching is required for the user
The coll is divided into two spherical parts Each half contains a 4 channel receive only array The coils were used together with a parallel imaging procedure.
Each coll has its own plug The plug is specific to the MRI-system and can't be mixed up with a not designated MRI-system
The base plate is flat and is suitable on each Siemens MRI-system table
2
5. Intended Use
The intended use of the Noras CPC is, in conjunction with a magnetic resonance scanner, body-imaging for diagnostic with a MRI system
It is indicated for use as a diagnostic imaging device transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body When interpreted by a trained physician, these unages provide information that can be useful in determining diagnosis
The application area shouldn't be bigger than 20 cm because of the depth of penetration of 10 cm per coll The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear, baby heart and other parts of the body with sımılar structure can be taken
6. Substantial Equivalence
Noras believes that, within the meaning of the Safe Medical Devices Act of 1990, the CPC multifunctional coil is substantially equivalent to the following coils.
| Coil Name | Premarket Notification | Clearance Date |
|---|---|---|
| Machnet Carotids Coil | ||
| Array Assembly | K 012491 | October 24, 2001 |
| Siemens Flex Loop | ||
| Coil Set 3T | K 063313 | November 17, 2006 |
| Invivo Precision Eight | ||
| Wrist Array Coil 1 5T | K 993477 | January 11, 1999 |
| Phased Array Shoulder Coil | K 963356 | November 22, 1996 |
| Model 455GE, Phased Array | ||
| Wrist Coil | K 010074 | April 3, 1996 |
| Model CG-WHC18-H150- | ||
| AP Wrist Hand Coil 1 5T | K 071882 | July 18, 2007 |
3
- Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Devices
The MRI multifunctional CPC coil has been designed to examine the internal structures of special regions of the human body To get MR images it is mandatory to use the loop colls of the MRT System manufacturer The approach of this new product was, to give the physician a more comfortable access to the region of interest in the internal structures of special regions of the human body to produce transverse, sagittal, coronal and oblique images, which provide information that can be useful in determining diagnosis
8. General Safety and Effectiveness Concerns
The complete system CPC will conform the harmonized standard of IEC 60601-1 30 edition. Medical electrical equipment - General requirements for basic safety and essential performance
The CPC coil will conform to the FDA recognized NEMA standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33 2003 This will assure that the performance of this device can be considered safe and effective when used with the currently available MAGNETOM systems
All tests are performed on the Siemens Avanto This is the most critical engine for safety and performance of the Siemens 1 5T series Passing these tests gives the Siemens approval for the complete 1 5T series
9. Conclusion as to Substantial Equivalence
Noras believes that, within the definition of the Safe Medical Devices Act of 1990, the Noras multifunctional CPC colls are substantially equivalent to the predicate devices listed above
$\frac{1}{2}$
Hubert Noras
President
1 -
1
November 27, 2008
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Image /page/4/Picture/1 description: The image shows a logo with a stylized eagle design. The eagle is depicted with three curved lines forming its body and wings. The logo is surrounded by text that reads 'U.S. Department of Health & Human Services, USA'. The text is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Mr Zahed Sedighianı Regulatory Affairs Manager Noras MRI Products GmbH Leibnizstr 4, Hochberg, 97204 GERMANY
Re K083578 Trade/Device Name CPC Regulation Number 21 CFR 892 1000 Regulation Name Magnetic resonance diagnostic device Regulatory Class II Product Code MOS Dated November 27, 2008 Received December 3, 2008
Dear Mr Sedighiani
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., Orug 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 regustration, 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
5
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 os 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 892 xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveyllance 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 Manufactures, 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 suppot/index html
Sincerely yours,
Janina M. Norris
anıne M Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (1f known) _ KOB 35 28
Device Name CPC
Indications for Use
The intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system
It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body When ınterpreted by a trained physician, these images provide information that can be use in determining diagnosis
The application area shouldn't be bigger than 20 cm because of the depth of 10 om per coll The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with sumilar structure can be taken
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)
Arnie Potte Wher
Division of Reproductive, Abdominal a Radiological Device 510(k) Number
(Posted November 13, 2003)