(75 days)
Not Found
No
The summary describes a standard MRI device and its intended use, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a diagnostic imaging tool (MRI) used to produce images and provide diagnostically useful information, not to treat or alleviate a condition.
Yes
The text explicitly states: "If interpreted by a medical expert, these images can provide diagnostically useful information." This indicates the device is intended to aid in diagnosis.
No
The device description clearly states it is a magnetic resonance imaging device with a physical magnet and open structure, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The Paramed Mr. Inspire is a Magnetic Resonance Imaging (MRI) device. It produces images of the internal structure of the body without taking any specimens. It uses magnetic fields and radio waves to create these images.
- Intended Use: The intended use clearly states it's for "diagnostic nuclear magnetic resonance imaging" of various anatomical sites. This is an in vivo (within the living body) diagnostic method, not in vitro.
The device provides diagnostically useful information, but it does so by imaging the body directly, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ Inspire device can also produce images of the C-Spine and L-Spine joinls. 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Mr Inspire is a magnetic resonance imaging device characterized by an open structure to minimize 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 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 (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.
Mentions image processing
Not Found
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, 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence is based on the design similarities and final inspection report data here referenced and kept in Paramed's files.
A table of the equivalence between the two models is hereunder supplied for the most important specified characteristics: .
| Parameter | Mr Inspire = MrJ |
|---|---|
| Magnetic field strength | 0.22 T |
| Stray field 5G | maximum 80 cm from magnet covers |
| Weight | 4200 Kg |
| Homogeneity |
§ 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
14100164 age 1/3
Special 510(K) Summary
The following Special 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(c).
Manufacturer Information
APR - 5 2010
Manufacturer:
Address:
Paramed Srl Corso Perrone 73R 16152 Genova, Italy 3004994584
Establishment registration number:
807.92(a)(1)
Submitter Information
Correspondent:
Joe Ouellette, 39 High Street North Andover, MA 01845 USA. 978.975.7530 x4345 Ph: 978.975.9930 Fax: Joe Ouellette,
Contact person:
807.92(a)(2)
| Trade Name: | Mr Inspire |
|---|---|
| Common Name: | Magnetic resonance diagnostic system |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification and class of device: 21 CFR 892.1000, class II |
Paramed s.r.l Sede Legale e Operativa: Corso 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 IVA 01195740095 - C.C.I.A.A. (REA) Genova 373591 Capitale Sociale € 15 600 1.V.
1
Image /page/1/Picture/0 description: The image shows the logo for "Paramed Medical Systems". The word "Paramed" is in a bold, sans-serif font, with each letter filled with a textured pattern. Below "Paramed" is the phrase "Medical Systems" in a smaller, sans-serif font. To the right of "Paramed" is a stylized, cursive design element.
Classification Number:
90LNH807.92(a)(3)
Predicate Devices
| Paramed | MrJ | K033507 |
|---|---|---|
| Paramed | MrJ Extended | K080098 |
807.92(a)(4)
The Mr Inspire is a magnetic resonance imaging device characterized by an open structure to minimize 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 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 (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)(5)
Device Intended Use(s)
The intended use of Paramed's Mr Inspire product 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).
807.92(a)(6)
Technological Characteristics
The Mr Inspire MRI system is substantially equivalent to
- . Paramed MrJ K033507 under all aspects except some very limited new function due to design restyling
- Paramed MrJ Extended K080098 under all the aspects excluding some design . restyling to keep the same drawing lines as the MrJ Inspire
Neither the intended use nor the technological characteristics of this model differ from those of the referenced models.
2
807.92(b)(1)
The determination of substantial equivalence is based on the design similarities and final inspection report data here referenced and kept in Paramed's files.
A table of the equivalence between the two models is hereunder supplied for the most important specified characteristics: .
| Parameter | Mr Inspire = MrJ |
|---|---|
| Magnetic field strength | 0.22 T |
| Stray field 5G | maximum 80 cm from magnet covers |
| Weight | 4200 Kg |
| Homogeneity |