MROPEN

K101295 · Paramed S.R.L. · LNH · Jul 28, 2010 · Radiology

Device Facts

• Record ID: K101295
• Device Name: MROPEN
• Applicant: Paramed S.R.L.
• Product Code: LNH · Radiology
• Decision Date: Jul 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging. MR Open tomograph produces transverse, sagittal, coronal and oblique crosssectional 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, spinlattice relaxation time (TI), 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.

Device Story

MrOpen 05 is a superconducting MRI system for total body diagnostic imaging. Device captures magnetic resonance signals from protons (hydrogen nuclei) to produce cross-sectional images (transverse, sagittal, coronal, oblique). Operates in both weight-free (supine) and weight-bearing positions. Used in clinical settings by trained physicians to visualize internal anatomy based on proton density, T1/T2 relaxation times, chemical shift, and flow velocity. Output images assist physicians in diagnostic decision-making. Benefits include ability to perform imaging in weight-bearing positions, potentially providing different diagnostic insights compared to traditional supine-only MRI.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Superconducting MRI system; open structure design. Supports weight-bearing and supine imaging. Standards: IEC 60601-1 (General Safety), IEC 60601-2-33, UL 94 (flammability), 21 CFR Subchapter J (Radiological Health). Connectivity: DICOM 3.0.

Indications for Use

Indicated for total body diagnostic imaging in patients. Excludes angiography, cardiac imaging, and breast imaging. Examinations performed in weight-free (supine) or weight-bearing positions.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• MrOpen Paramed (K073362)

Submission Summary (Full Text)

{0}------------------------------------------------

K101295
page 1/2

JUL 28 2010

: IEC standards: IEC 60601-1, International Electrotechnical Commission, Medical Electrical Equipment, Part 1: General Requirements for Safety IEC 60601-2-33 UL standards: UL 94 Tests for Flammability of Plastic Materials for Parts in Devices and Appliances FDA standards: Regulations under 21 CFR Subchapter J -Radiological Health Voluntary standards: DICOM 3.0

# A.3.9 510(K) Summary of Safety and Effectiveness

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

## Manufacturer Information

| Manufacturer: | Paramed Srl |
|------------------------------------|------------------------------------------|
| Address: | Corso Perrone 73R<br>16152 Genova, Italy |
| Establishment registration number: | 3004994584 |

## 807.92(a)(1)

## Submitter Information

Correspondent: Correspondent

Richard R. Glasheen (from 2010-05-10 on),

39 High Street North Andover, MA 01845 USA. Ph. 978.975.7530 x4345 Fax: [phone]

Contact person:

Richard R. Glasheen (from 2010-05-10 on),

{1}------------------------------------------------

## 807.92(a)(2)

| Trade Name: | MrOpen 05 |
|-------------------------------------|----------------------------------------------------|
| Common Name: | Total Body Magnetic resonance diagnostic<br>device |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification and class of device: | 21 CFR 892.1000, class II |
| Classification Number: | 90LNH |

## 807.92(a)(3)

Predicate Devices

MrOpen Paramed

K073362

## 807.92(a)(5)

#### Device Intended Use(s)

The intended use of Paramed's MrOpen 05 product is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging. MrOpen tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the anatomies. The examinations may be performed both in weight free (supine) and weight bearing position.

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 (TI), 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.

#### 807.92(a)(6)

#### Technological Characteristics

The MrOpen 05 MRI system is substantially equivalent to

- Paramed MrOpen K073362 as a total body open structure superconducting MRI . Scanner

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping human figures.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Paramed Srl % Mr. Richard R. Glasheen Correspondent 39 High Street NORTH ANDOVER MA 01845

JUL 2 8 2010

Re: K101295

Trade/Device Name: MR Open 0.5T Regulation Number: 21 CFR 892.1000 . Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNI Dated: April 28, 2010 Received: May 10, 2010

Dear Mr. Glasheen:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

K101295

510(k) Number (if known): k101295

JUL 2 8 2010

Device Name: MR Open 0.5T

Indications for Use:

"The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging.

MR Open tomograph produces transverse, sagittal, coronal and oblique crosssectional 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, spinlattice relaxation time (TI), 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 807 Subpart C)

Page 1 of

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDBH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K101295