(148 days)
Not Found
No
The document describes a standard MRI device and its equivalence to predicate devices. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of such technologies. The focus is on the hardware (magnet, coils, covers) and basic imaging sequences.
No
The device is strictly described as a "diagnostic imaging device" intended to "yield information that can be useful in the determination of a diagnosis," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The MrJ 3300 is indicated for use as a diagnostic imaging device." It also mentions that the images produced "can yield information that can be useful in the determination of a diagnosis" when interpreted by a trained physician.
No
The device description clearly details physical hardware components such as a magnet, covers, positioning LED, positioning touch screen, and receiving coils, indicating it is a hardware-based medical device, not software-only.
Based on the provided text, the MrJ 3300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- MrJ 3300's Function: The MrJ 3300 is a Magnetic Resonance Imaging (MRI) device. It produces images of the internal structure of the body by utilizing magnetic fields and radio waves. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is a "diagnostic imaging device" that produces "cross-sectional images" of various joints and spinal regions. This is consistent with the function of an imaging device, not an IVD.
Therefore, the MrJ 3300 falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).
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 MrJ 3300 is a magnetic resonance imaging device characterized by an open structure to minize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.
Mentions image processing
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 (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can vield information that can be useful in the determination of a diagnosis.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging
Anatomical Site
hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / very small hospital and clinics
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
On the basis of the internal final inspection data reports, summarized in the above 807.92(b)(1) and (b)(2) point and of the test images performed both on phantoms and on healthy volunteers, we declare that the MrJ 3300 device is at least as safe and effective as the predicate devices.
Summary of Performance Studies
Nonclinical tests that demonstrate performance towards relevant standards:
- IEC 60601-1 Electrical safety: Conform
- IEC 60601-1-2 Electromagnetic compatibility: Conform
- IEC 60601-1-4 Programmable devices: Conform, Sw release n.1.A.3
- IEC 60601-2-33 Operation mode: Normal Controlled Operation Mode
- IEC 60601-2-33 SAR Whole Body: 0.66 +/- 0.10 W/Kg
- IEC 60601-2-33 SAR Head: 0.9 +/- 0.6 W/Kg
- IEC 60601-2-33 SAR Exposed Body: 0.66 +/- 0.10 W/Kg
- IEC 60601-2-33 max dB/dt: Conform, 19,8 T/s with τ = 600 μs, Gradient coil diameter 850 mm
- IEC 60601-2-33 max Acoustic noise Level A-weighted L eq: Conform (
§ 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
PARAMed
MEDICAL SYSTEMS
510(K) Summary
Date 05/07/2012
The following Special 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(c).
Manufacturer Information
Manufacturer:
Address:
Paramed Srl Corso Perrone 73R 16152 Genova, Italy 3004994584.
Establishment registration number:
807.92(a)(1)
Submitter Information Correspondent:
Contact Person
ichard Olson, Correspondent USA Paramed Medical Systems, Inc 6204 W. Oakton Street Morton Grove, IL 60053 Toll Free: 1 866 840-7565 T 1 847 470-0580nF 1 847 470-0612 Luisella De Benedetti Paramed S.r.l. Corso F.M. Perrone 73R 16152 Genova +39 010 6489 358 luisella.debenedetti@paramed.it
807.92(a)(2)
Classification Name(s):
Classification Number:
Trade Name:
Common Name:
MrJ 3300
Magnetic resonance diagnostic system System, Nuclear Magnetic Resonance Imaging 21 CFR 892.1000, class II Classification and class of device:
90LNH
807.92(a)(3)
Predicate Devices
Section A
| Paramed | MrJ | K033507 |
|---|---|---|
| Paramed | MrJ Inspire | K100164 |
| Paramed | MrOpen 05T | K101295 |
| Paramed | Performance Package | K121249 |
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681245
20
DEC 0 6 2012
1
807.92(a)(4)
ction A
The MrJ 3300 is a magnetic resonance imaging device characterized by an open structure to minize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.
It is indicated for use as a diagnostic imaging device that produces transverse, sagittal. coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot; shoulder, elbow, wrist; hand, calf, thigh, arm, forearm. Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography). ....
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 (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can vield information that can be useful in the determination of a diagnosis. ... .
The MrJ 3300 has a 0,3 T magnet, which has a higher intensity than the predicate one (0,2T). Of course the new 0,3 T magnet with slightly different dimensions needs a new design of covers and some modest upgrades due to design ageing of the MrJ Inspire 01-2000-01 product.
New covers of the system have been designed by the same company which designed MRJ Inspire's covers and they have been manufactured using the same C-UL-US approved fire protection materials.
The MrJ 3300 employs both the positioning LED (K033507) and the positioning touch screen . (K100164) to give to the user the maximum chances to get rapidly to the correct patient of positioning.
The scanning sequences are the same employed in MrJ Inspire model (K100164) unless the FLAIR sequences which are equivalent to the same FLAIR sequences employed on the MrOpen 05 T K101295 device.
The MrJ 3300 is furnished with the Performance Package of new concept receiving coils . (code 06-0096-00) equivalent to the Performance Package K121249.
2
807.92(a)(5)
Device Intended Use(s)
The intended use of Paramed's MrJ 3300 product is the same than the intended use of the predicate one: it is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).
The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation i time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift), If interpreted by a medical expert, these images can provide diagnostically useful information.
807.92(a)(6)
Section A
Technological Characteristics
The MrJ 3300 MRI system is substantially equivalent to:
- Paramed Mr Inspire K033507 for intended use. � architecture, software and positioning LED system. . . . . . ::::: .
- Paramed Mr Inspire K100164 for intended use, covers' materials, and Touch panel positioning system.
- Paramed MrOpen 05T K101295 for the FLAIR sequences
- Paramed Performance Package K121249 (C-Spine coil, L-Spine coils, MP_wrap coil) complete equivalence except the working frequency which here is centered at 13 MHz due to the higher magnetic field.
12
10/? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
Neither the intended use nor the technological characteristics of this model differ from those of the referenced models. A table is supplied later on regarding design similarities.
3
807.92(b)(1)
The discussion of the nonclinical, tests submitted, referenced, or in the premarket notification submission for a determination of substantial equivalence.
The nonclinical tests are summarized in this submission.
The aim of the nonclinical test is to demonstrate performance towards the relevant standards listed in form 3514. :
| Parameter | MrJ 3300 | MrJ Inspire with
Extended Kit
K100164 |
|------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| IEC 60601-1 Electrical safety | Conform | Conform |
| IEC 60601-1-2 Electromagnetic
compatibility | Conform | Conform |
| IEC 60601-1-4 Programmable devices | Conform
Sw release n.1.A.3 | Conform
Sw release n. 1.A.3 |
| IEC 60601-2-33 Operation mode | Normal Controlled Operation Mode | Normal Controlled
Operation Mode |
| IEC 60601-2-33 SAR
Whole Body | 0.66 +/- 0.10 W/Kg | 0,57 +/- 0,15 W/Kg |
| Head | 0.9 +/- 0.6 W/Kg | - |
| Exposed Body | 0.66 +/- 0.10 W/Kg | - |
| IEC 60601-2-33 max dB/dt | Conform
19,8 T/s with $\tau$ = 600 $\mu$ s
Gradient coil diameter 850 mm | Conform
19,8 T/s with $\tau$ = 600 $\mu$ s
Gradient coil diameter 850
mm |
| IEC 60601-2-33 max Acoustic noise
Level A-weighted L eq | Conform (