(175 days)
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Not Found
No
The summary describes a standard MRI device and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is described as a diagnostic imaging device used to produce images for interpretation by a physician to determine a diagnosis, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for use as a diagnostic total body imaging device" and that the images produced "can yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly states it is a "total body magnetic resonance imaging device," which is a hardware-based imaging system.
Based on the provided information, the MROpen device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- MROpen Function: The description clearly states that the MROpen is a magnetic resonance imaging device that produces images of the internal structure of the body. It works by using magnetic fields and radio waves to create images of tissues and organs within the patient.
Therefore, the MROpen is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MROpen is a total body magnetic resonance imaging device, It is indicated for use as a diagnostic total body imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
Product codes
LNH
Device Description
The MROpen is a total body magnetic resonance imaging device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
total body
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 logo for "Paramed Medical Systems". The word "Paramed" is in a bold, sans-serif font, with the "d" having a stylized, cursive extension. Below "Paramed" is the text "MEDICAL SYSTEMS" in a smaller, sans-serif font. The overall impression is a professional and modern logo for a medical company.
MAY 2 3 2008
H. Safety and Effectiveness Information
H. 1 510(k) Statement - Safety & Effectiveness Letter Date: 23/11/27
510(k) Status Coordinator
FDA, Center for Devices & Radiological Health (HFZ-401)
9200 Corporate Blvd.
Rockville, MD 20850
510(k) Statement - Safety & Effectiveness Letter REFERENCE: Included with 510(K) Notification
PARAMED SRL
I certify that, in my capacity as Authorized officier of Paramed Srl, I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be in a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
All requested information should be directed to the following:
Michael A. Douglas 39 High Street North Andover, MA 01845 USA. 978.975.7530 x4345 Ph: 978.975.9930 Fax:
Sincerely,
Gian Enrico Tardivelli, Authorized Officier
Paramed Srl
Gardivell
aramed & I Sede I enale e Onerativa orso F M. Perrone, 73r - 16152 Genova Tel. Fax- ++39 010 7404530 e-mail: info@paramed.it - www.paramed.it
Codice Fiscale e Iscrizione al Registro delle Imprese di Genova 01195740095 P. NA 01195740095 - C.C.I.A.A. (REA) Genova 373591 Capitale Sociale € 15 600 I.V.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2008
Paramed Srl % Mr. Michael A. Douglas Correspondent 39 High Street NORTH ANDOVER MA 01845 USA
Re: K073362
Trade/Device Name: MrOpen Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 19, 2008 Received: May 1, 2008
Dear Mr. Douglas:
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.
2
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. Mourmust 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 ss 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 24/1276-3474. 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 max 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/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C. Burgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K073362 510(k) Number (if known):
Device Name: Mr©pen
Indications For Use
Indications For Use: The MROpen is a total body magnetic resonance imaging device,
It is indicated for use as a diagnostic total body imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart CJ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER.PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (GDE)
Page 1 of __ 1
Arqui. F. Wz
(Division Sign Off) (Division of Reproductive, Abdominal and Radiological Devic 510(k) Number