(90 days)
The Artoscan S is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints 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), spinspin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The Artoscan S is a magnetic resonance diagnostic device. It is a "C" shaped Neodymium alloy permanent magnet system with a static field strength of 0.18 T. It has solenoidal and DPA receiver coils designed for specific anatomical sites. The system includes a central processing unit, control processor, acquisition and reconstruction processor, hard disk unit, rewritable optical disk unit, and a display monitor. It supports various data acquisition modes and pulse sequences, allowing for different slice thicknesses, orientations, and acquisition matrices. The device also includes automatic and non-automatic image filtering capabilities and networking functions for printing and sending images in DICOM3 protocol form. It is designed for fixed area installation.
Here's a summary of the acceptance criteria and the study information for the Artoscan S device, based on the provided text.
This document describes the Artoscan S MRI system and its substantial equivalence to previously marketed devices (predicates ARTOSCAN M, AIRIS, and PRIMA 1TG). The submission focuses on comparing the technical characteristics of the Artoscan S to these predicates rather than presenting a performance study with specific acceptance criteria that the device had to meet through a clinical trial.
It's crucial to understand that this submission is a 510(k) for substantial equivalence, not a premarket approval (PMA) application. Therefore, it does not contain a typical clinical study designed to "prove" the device meets detailed performance acceptance criteria in terms of diagnostic accuracy or efficacy. Instead, it demonstrates that the device is as safe and effective as existing legally marketed devices.
The "acceptance criteria" in this context are interpreted as the technical specifications and clinical uses that the Artoscan S demonstrates to be substantially equivalent to the predicate devices. The "reported device performance" is the Artoscan S's claimed capabilities based on its design and comparison to the predicates.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate devices. The reported performance of the Artoscan S matches or improves upon the predicate devices in various technical and clinical use categories.
| Characteristic | Acceptance Criterion (from Predicates) | Reported Artoscan S Performance | Device Meets Criteria? |
|---|---|---|---|
| Clinical Use | Orthopedic regions, including knee, leg, ankle, foot, hand, wrist, forearm, elbow | Knee, leg, ankle, foot, hand, wrist, forearm, elbow, shoulder, hip | Yes (Expanded) |
| Field of View (FOV) | 50 to 350 mm diameter (AIRIS) | 100 to 300 mm, step 10 mm (140 mm displayed) | Yes (Specific to limbs) |
| Type of Magnet | "C" shaped Neodymium alloy permanent magnet | "C" shaped Neodymium alloy permanent magnet | Yes |
| Static Field Strength | 0.3 T (AIRIS); unspecified (ARTOSCAN M) | 0.18 T | Yes (Within range of similar low-field systems) |
| Fringe Field | 5 G line at 2.5 m max (AIRIS) | 5 G line at 1.4 m maximum | Yes (Improved/Less) |
| Gantry Opening | 1000 x 380 mm (AIRIS) | 620 mm x 240 mm (w x h) | Yes (Specific to limb MRI) |
| Radiographic System Coils | Solenoidal and DPA coils for joints | Solenoidal (Shoulder/Knee, Hip) and DPA (Knee, Ankle, Hand/Wrist) coils with different shapes | Yes (New shapes for gantry/limbs) |
| RF Power | up to 5000 W peak pulse (AIRIS) | up to 600 W peak pulse | Yes (Lower, suitable for low-field) |
| Patient Comfort | Large magnet opening to reduce claustrophobia | Large magnet opening, patient mostly out of magnet | Yes (Enhances comfort) |
| Patient Positioning | Adjustable table/couch for limb positioning | Adjustable couch, manual push into gantry | Yes (Similar philosophy) |
| Installation Area | 4m x 5m (scanner) + 4m x 2.5m (console) (AIRIS)Fixed or mobile (ARTOSCAN M) | 3.7 m x 3.7 m (Fixed area only) | Yes (Smaller footprint, fixed installation) |
| RF Shielding | External shielding to 60 dB (AIRIS)Self-contained or external shielding (ARTOSCAN M) | Self-contained (up to 30 dBμV/m), External (up to 100 dBμV/m) | Yes |
| Gradient Strength | 21 mT/m (PRIMA 1TG whole-body set) | 20 mT/m | Yes (Comparable, with noted spatial resolution improvement potential) |
| Rise Time (Gradients) | 0.5 msec to full amplitude (PRIMA 1TG) | 0.5 msec from 0 to 20 mT | Yes |
| Data Acquisition Modes | Spin warp 2D/3D, Half Scan, Half Echo (ARTOSCAN M) | Spin warp 2D/3D, Half Scan, Half Echo | Yes (Unchanged) |
| Pulse Sequences | Comprehensive list (ARTOSCAN M) | Identical comprehensive list (ARTOSCAN M) | Yes (Unchanged) |
| Slice Thickness | 2D FT: 2-10 mm; 3D FT: 0.6-10 mm (ARTOSCAN M) | 2D FT: 2-10 mm; 3D FT: 0.6-10 mm | Yes (Unchanged) |
| Interslice Spacing | Contiguous slicing available (ARTOSCAN M) | Contiguous slicing available | Yes (Unchanged) |
| Slice Orientation | Transverse, Sagittal, Coronal, Oblique, Multislice (ARTOSCAN M) | Transverse, Sagittal, Coronal, Oblique, Multislice | Yes (Unchanged) |
| Acquisition Matrix | 2D FT: 192x128 to 256x256; 3D FT: 192x128 to 256x256 (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Spatial Resolution | Up to 0.4 mm (ARTOSCAN M) | Up to 0.4 mm | Yes (Unchanged) |
| Multi-slice / Multi-echo | 128 slices max/2 echoes max (ARTOSCAN M) | 128 slices max/2 echoes max | Yes (Unchanged) |
| Scan Parameters (TR, TE, TI, FA) | Various range limits (ARTOSCAN M) | Largely identical, some shorter TEs due to higher gradient strength | Yes (Substantially unchanged, improved for some sequences) |
| Image Reconstruction Time | 2D: 1 sec/img; 3D: ≈ 35 sec (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Display Matrix | Format1: 510x478; Format4: 254x238 (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Grey Scale | 2D: 4096; 3D: 256 (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Image Filtering | Automatic and non-automatic adaptive/non-adaptive filters (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Networking Functions | DICOM3 printing/sending, TCP/IP, PPP (ARTOSCAN M) | Identical | Yes (Unchanged) |
Study Information (Based on a 510(k) Submission)
This document is a 510(k) Premarket Notification for substantial equivalence. It does not describe a clinical study in the typical sense of prospectively gathering patient data to prove diagnostic accuracy against a gold standard. Instead, it relies on demonstrating that the Artoscan S is as safe and effective as its predicate devices by comparing their technical features and intended uses.
-
Sample size used for the test set and the data provenance: Not applicable. The submission is a technical comparison, not a clinical trial with a "test set" of patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "test set" with ground truth established by experts is described for this 510(k) submission. The safety and effectiveness are established by the substantial equivalence to predicate devices, which would have undergone their own regulatory evaluations (potentially including clinical data for their initial clearance).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical "test set" and thus no adjudication method is mentioned.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an MRI device itself, not an AI-assisted diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical imaging system, not an algorithm being evaluated independently.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the technical performance of the device meeting established MRI principles and being comparable to legally marketed predicate devices.
-
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
-
How the ground truth for the training set was established: Not applicable.
In summary, the provided document demonstrates substantial equivalence by thoroughly comparing the technical specifications and intended uses of the Artoscan S with three cleared predicate MRI devices (ARTOSCAN M, AIRIS, and PRIMA 1TG). The "proof" is in demonstrating that the Artoscan S has similar indications for use and addresses any differences in technology in a manner that does not raise new questions of safety or effectiveness. The FDA's letter explicitly states that the device is "substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976...or to devices that have been reclassified."
{0}------------------------------------------------
JUL 1 3 1898
Safety and Effectiveness Summary Artoscan S Biosound Esaote
Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to The following surcey and commaries specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Submitter Information
| Colleen Hittle, Official Correspondent |
|---|
| 8000 Castleway Drive |
| Indianapolis, IN 46250 |
| Phone: | (317) 849-1916 |
|---|---|
| Facsimile: | (317) 577-9070 |
| Contact Person: | Colleen Hittle |
|---|---|
| Date: | March 25, 1998 |
807.92(a)(2)
FDA/CDRH/ODE/DMC
14 APR 98 09 57
Artoscan S Trade Name: Magnetic resonance diagnostic device Common Name: System, Nuclear Magnetic Resonance Imaging Classification Name(s):
90LNH Classification Number:
807.92(a)(3)
| Esaote | Artoscan M | K963262 |
|---|---|---|
| Hitachi | AIRIS | K945155 |
| Elscint | PRIMA 1TG | K970990 |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
Predicate Device(s)
{1}------------------------------------------------
Imaging System 1.
ERR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
,在
| Characteristic | ARTOSCAN S | AIRISK945155 | Comments |
|---|---|---|---|
| Clinical use | Knee, leg, ankle, foot,hand, wrist, forearm,elbow, shoulder, hip. | Whole body, centralnervous system andorthopaedic regions. | Two new joints(hip andshoulder) havebeen introducedfor examination. |
| Field of view | From 100 up to 300 mm,step 10 mm (140 mm aredisplayed). | From 50 up to 350 mm indiameter. | A larger FOVhas been realizedto better coverthe anatomicalparts to beimaged. |
1. Magnetic System
| Characteristic | ARTOSCAN S | AIRISK945155 | Comments |
|---|---|---|---|
| Type of magnet | "C" shaped Neodymiumalloy permanent magnet. | "C" shaped Neomax™(Neodymium alloy)permanent magnet. | |
| Static fieldstrength | 0.18 T (perpendicular topatient's body). | 0.3 T (perpendicular topatient's body). | |
| Fringe field | 5 G line at 1.4 mmaximum from the centreof the magnet. | 5 G line at 2.5 mmaximum from the centreof the magnet. | |
| Gantry opening | 620 mm x 240 mm (w x h) | 1000 x 380 mm(w x h) | |
| Magneticsystem weight | 1700 kg | 10000 kg |
Radiofrequency System 1.
| Characteristic | ARTOSCAN S | AIRISK945155 | Comments |
|---|---|---|---|
| Solenoidalreceiver coils | Shoulder/Knee Coil17.5x7.6x14.7 cmHip Coil20 x 23 x 14 cm(internal dimensions: w x d x h) | Large joint Coil (shoulder, knee)18.4x23 cm wxhFlexible body Coil (hip and other regions)20x150 cm wxd | The technology of the solenoidal (or linear) coils is unchanged compared to the technology used for the ARTOSCAN M coils. Coils with different shapes |
{2}------------------------------------------------
| Characteristic | ARTOSCAN S | AIRISK945155 | Comments |
|---|---|---|---|
| have beendeveloped toadapt to thegeometricalcharacteristics ofthe gantry and tothe new limbs toexamine. | |||
| RF power | up to 600 W peak pulse | up to 5000 W peak pulse |
Patient Positioning 1.
、
| Characteristic | ARTOSCAN S | AIRIS K945155 | Comments |
|---|---|---|---|
| Patient comfort | The large magnet openingand the device design, thatallows the patient to bealmost completely out ofthe magnet, except theexamined portion, virtuallyeliminate claustrophobiaand other related reactionsduring the examination. | The large magnet openingvirtually eliminates theanxiety and claustrophobiaoften experienced bypatients in the narrow boreof conventional MR imag-ing systems. | |
| Patientpositioning | An adjustable couch isused to position thepatient's limb inside thegantry.The couch is pushed intothe gantry manually. | An adjustable motorizedtable is used to position thepatient inside the gantry. | The samepositioningphilosophy asARTOSCAN M,suitable for thenew gantryshape, has beenused forARTOSCAN S. |
:
{3}------------------------------------------------
Installation Area Conditions 1.
: 上一篇:
,
| Characteristic | ARTOSCAN S | AIRISK945155 | Comments |
|---|---|---|---|
| Area necessary | 3.7 m x 3.7 m | 4 m x 5 m (gantry andpatient table)4 m x 2.5 m (operatorconsole, MRI unit andother components) | |
| RF shielding | Self contained RFshielding (up to 30dBμV/m).External shielding (up to100 dBμV/m). | The scan room must be RFshielded to 60 dB. RFnoise inside the scan roomshould meet 0.5-30 MHz,0 dBμV/m or less. |
2. Magnetic System
| Characteristic | ARTOSCAN S | PRIMA 1TGK970990 | Comments |
|---|---|---|---|
| Gradientstrength | 20 mT/m | whole-body set21 mT/m | With highergradient strengthit is possible tominimize at thesame time FOVand slicethickness, alsofor sequenceswith very shortTE, improvingthe spatialresolution. |
| Rise time | 0.5 msec from 0 to 20 mTor from -20 to 0 mT | 0.5 msec to full amplitudesupplementary set30 mT/m0.41 msec to full amplitude | |
| Characteristic | ARTOSCAN S | ARTOSCAN MK963262 | Comments |
| Dataacquisitionmodes | Spin warp 2D/3DHalf ScanHalf Echo | Spin warp 2D/3DHalf ScanHalf Echo | Unchanged |
| Pulse sequences | Multiplanar Ortho-ScoutT1-weighted Spin Echo(SET1)T2-weighted Spin Echo(SET2)Multiple Spin-Echo(MEDE)Gradient Echo (GE)Inversion Recovery (IR)Short TI InversionRecovery (STIR)Half Echo T1-weightedSpin Echo (SET1HE)Half Fourier T1-weightedSpin Echo (SET1HF)Turbo T2-weighted Spin-Echo (TSE)Turbo Multiple Spin-Echo(TME)Turbo Gradient Echo(TGE)3D Gradient Echo (GE3D)Turbo 3D T1-weightedGradient Echo (T3D_T1)Turbo 3D T2-weightedGradient Echo (T3D_T2)Short TI InversionRecovery Gradient Echo(GEFS)Magnetization Transfer(GEMT)3D Magnetization Transfer(GE3DMT) | Multiplanar Ortho-ScoutT1-weighted Spin Echo(SET1)T2-weighted Spin Echo(SET2)Multiple Spin-Echo(MEDE)Gradient Echo (GE)Inversion Recovery (IR)Short TI InversionRecovery (STIR)Half Echo T1-weightedSpin Echo (SET1HE)Half Fourier T1-weightedSpin Echo (SET1HF)Turbo T2-weighted Spin-Echo (TSE)Turbo Multiple Spin-Echo(TME)Turbo Gradient Echo(TGE)3D Gradient Echo (GE3D)Turbo 3D T1-weightedGradient Echo (T3D_T1)Turbo 3D T2-weightedGradient Echo (T3D_T2)Short TI InversionRecovery Gradient Echo(GEFS)Magnetization Transfer(GEMT)3D Magnetization Transfer(GE3DMT) | Unchanged |
| Slice thickness | 2D FT: from 2 mm to 10mm, step 0.5 mm3D FT: from 0.6 mm to 10mm, step 0.1 mm | 2D FT: from 2 mm to 10mm, step 0.5 mm3D FT: from 0.6 mm to 10mm, step 0.1 mm | Unchanged |
| Interslicespacing | Not necessary: contiguousslicing is available | Not necessary: contiguousslicing is available | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN M K963262 | Comments |
| Slice orientation | TransverseSagittalCoronalObliqueMultislice packages | TransverseSagittalCoronalObliqueMultislice packages | Unchanged |
| Acquisition matrix | 2D FT: from 192x128 up to 256x256; phase encoding step 83D FT: from 192x128 up to 256x256; slice encoding from 8 to 128, step 8; phase encoding step 8 | 2D FT: from 192x128 up to 256x256; phase encoding step 83D FT: from 192x128 up to 256x256; slice encoding from 8 to 128, step 8; phase encoding step 8 | Unchanged |
| Spatial resolution | Up to 0.4 mm. | Up to 0.4 mm. | Unchanged |
| Multi-slice | 128 slices max (for each echo) | 128 slices max (for each echo) | Unchanged |
| Multi-echo | 2 echoes max | 2 echoes max | Unchanged |
| Scan parameters | TRSET1: 50 ~ 5000 ms, step 10 msSET2: 200 ~ 5000 ms, step 10 msMEDE: 200 ~ 5000 ms, step 10 msGE: 60 ~ 5000 ms., step 10 msIR: 260 ~ 5000 ms, step 10 msSTIR: 100 ~ 5000 ms, step 10 msSET1HE: 50 ~ 5000 ms, step 10 msSET1HF: 50 ~ 5000 ms, step 10 msTSE: 200 ~ 5000 ms, step 10 msTME: 200 ~ 5000 ms., step 10 msTGE: 30 ~ 5000 ms, step 5 msGE3D: 40 ~ 5000 ms, step 10 msT3D_T1: 25 ~ 5000 ms, step 5 ms | TRSET1: 50 ~ 5000 ms, step 10 msSET2: 200 ~ 5000 ms, step 10 msMEDE: 200 ~ 5000 ms, step 10 msGE: 60 ~ 5000 ms., step 10 msIR: 260 ~ 5000 ms, step 10 msSTIR: 100 ~ 5000 ms, step 10 msSET1HE: 50 ~ 5000 ms, step 10 msSET1HF: 50 ~ 5000 ms, step 10 msTSE: 200 ~ 5000 ms, step 10 msTME: 200 ~ 5000 ms., step 10 msTGE: 30 ~ 5000 ms, step 5 msGE3D: 40 ~ 5000 ms, step 10 msT3D_T1: 25 ~ 5000 ms, step 5 ms | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN MK963262 | Comments |
| T3D_T2 : 35 ~ 5000 ms,step 1 ms | T3D_T2 : 35 ~ 5000 ms,step 1 ms | ||
| GEFS: 70 ~ 5000 ms., step10 ms | GEFS: 70 ~ 5000 ms., step10 ms | ||
| GEMT: 40 ~ 5000 ms,step 5 ms | GEMT: 40 ~ 5000 ms,step 5 ms | ||
| GE3DMT: 45 ~ 5000 ms,step 5 ms | GE3DMT: 45 ~ 5000 ms,step 5 ms | ||
| TE | SET1: 16~34 ms, step 2 ms | SET1: 18 ~ 34 ms, step 2 ms | The sequencesare substantiallyunchanged. Forsome sequenceswe used shorterTE, to obtain amore T1-weightedcontrast. That ispossible thanksthe highergradient strength. |
| SET2: 80~ 120 ms, step10 ms | SET2: 80~ 120 ms, step10 ms | ||
| MEDE: 1st echo 38 ms;2nd echo 90 ms | MEDE: 1st echo 38 ms;2nd echo 90 ms | ||
| GE: 12 ~ 24 ms, step 2 ms | GE: 12 ~ 24 ms, step 2 ms | ||
| IR: 16 ~ 34 ms, step 2 ms | IR: 18~34 ms, step 2 ms | ||
| STIR: 16 ~ 34 ms, step 2ms | STIR: 18 ~ 34 ms, step 2ms | ||
| SET1HE: 10 ~ 24 ms, step2 ms | SET1HE: 12 ~ 24 ms, step2 ms | ||
| SET1HF: 16 ~ 34 ms, step2 ms | SET1HF: 18 ~ 34 ms, step2 ms | ||
| TSE: 80 ~ 120 ms, step 10ms | TSE: 80 ~ 120 ms, step 10ms | ||
| TME: 1st echo 38 ms; 2ndecho 90 ms | TME: 1st echo 38 ms; 2ndecho 90 ms | ||
| TGE: 8 ~ 24 ms, step 1 ms | TGE: 8 ~ 24 ms, step 1 ms | ||
| GE3D: 8 ~ 24 ms, step 1ms | GE3D: 14~24 ms, step 2ms | ||
| T3D_T1: 8~24 ms, step1 ms | T3D_T1: 8~24 ms, step1 ms | ||
| T3D_T2 : fixed at 16 ms | T3D_T2 : fixed at 16 ms | ||
| GEFS: 8 ~ 24 ms, step 1ms | GEFS: 12 ~ 24 ms, step 2ms | ||
| GEMT: 8 ~ 24 ms, step 1ms | GEMT: 8 ~ 24 ms, step 1ms | ||
| GE3D MT: 8 ~ 24 ms, step1 ms | GE3D MT: 8 ~ 24 ms, step1 ms | Unchanged | |
| TI | IR: 200 ~ 800 ms, step 10ms | IR: 200 ~ 800 ms, step 10ms | |
| STIR: 50~200 ms, step 5ms | STIR: 50~200 ms, step 5ms | ||
| Characteristic | ARTOSCAN S | ARTOSCAN MK963262 | Comments |
| GEFS : 20 ~ 200 ms, step5 ms | GEFS : 20 ~ 200 ms, step5 ms | ||
| FA | FA | Unchanged | |
| GE: fixed at 90º | GE: fixed at 90º | ||
| TGE: 10º ~ 90º, step 5º | TGE: 10º ~ 90º, step 5º | ||
| GE3D: 10º ~ 90º, step 5º | GE3D: 10º ~ 90º, step 5º | ||
| T3D_T1: 10º ~ 90º, step5º | T3D_T1: 10º ~ 90º, step5º | ||
| T3D_T2 : fixed at 90º | T3D_T2 : fixed at 90º | ||
| GEFS : fixed at 90º | GEFS : fixed at 90º | ||
| GEMT: 10º~ 90º, step 5º | GEMT: 10º ~ 90º, step 5º | ||
| GE3DMT: 10º ~ 90º, step5º | GE3DMT: 10º ~ 90º, step5º |
{4}------------------------------------------------
3. Imaging System
の人気の人気の人気の人気の人気の人気の
»
{5}------------------------------------------------
:
:
{6}------------------------------------------------
.
:
{7}------------------------------------------------
3. Radiofrequency System
| Characteristic | ARTOSCAN S | ARTOSCAN M | Comments |
|---|---|---|---|
| DPA receivercoils | DPA Knee Coil14.2x17.8x15.8 cmDPA Ankle Coil8.7x21.4x14.6 cmDPA Hand/Wrist Coil7.2x18.6x11.9 cm(internal dimensions: w x dx h) | DPA Knee Coil12.5x19.3x13.7 cmDPA Ankle Coil8.7x21.4x14.6 cmDPA Hand/Wrist Coil7.2x18.6x11.9 cm(internal dimensions: w x dx h) | The technologyof the DPA (orquadrature) coilsis unchangedcompared to thetechnology usedfor theARTOSCAN Mcoils. A morecomfortable kneecoil has beendeveloped. |
3. Image Processing and Display System
| Characteristic | ARTOSCAN S | ARTOSCAN M | Comments |
|---|---|---|---|
| Centralprocessing unit | CPU: Pentium 200 MHzMain memory: 32 MB;256 KB cache memory | CPU: Pentium 200 MHzMain memory: 32 MB;256 KB cache memory | Unchanged |
| Controlprocessor | 16.7 MIPS, 0.5 MBmemory | 16.7 MIPS, 0.5 MBmemory | Unchanged |
| Acquisition andreconstructionprocessor | 33 MFlops, 65 MBmemory | 33 MFlops, 65 MBmemory | Unchanged |
| Hard disk unit | 3"½; 2.6 GB | 3"½; 2.6 GB | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN M | Comments |
| Rewritableoptical disk unit | 3"½, R/W, 640 MB, 1 side | 3"½, R/W, 640 MB, 1 side | Unchanged |
| Imagereconstructiontime | 2D1 sec/img in Format1 withvisualization0.8 sec/img in Format4with visualization3D≈ 35 sec for reconstructinga 256x256x128 data cube,to calculate the three Scoutimages and to save theimage cube (256x256x128,8 bit/pixel) | 2D1 sec/img in Format1 withvisualization0.8 sec/img in Format4with visualization3D≈ 35 sec for reconstructinga 256x256x128 data cube,to calculate the three Scoutimages and to save theimage cube (256x256x128,8 bit/pixel) | Unchanged |
| Display matrix | Format1: 510x478;Format4: 254x238; | Format1: 510x478;Format4: 254x238; | Unchanged |
| Grey scale | 4096 (0+4095) Greylevels in 2D256 Grey levels in 3D | 4096 (0+4095) Greylevels in 2D256 Grey levels in 3D | Unchanged |
| Displaymonitor | 17" Colour 640x480 pixel,60 Hz non-interleaved,high contrast | 17" Colour 640x480 pixel,60 Hz non-interleaved,high contrast | UnchangedThe DHHSAccessionNumber is:9531534-07. |
| Image filtering | Automatic image filteringin visualization by anadaptive filter, dependingon the image acquisitionparameters characterizingthe image to be filtered.Non-automatic imagefiltering by three types ofadaptive filters and twotypes of non-adaptive fil-ters. | Automatic image filteringin visualization by anadaptive filter, dependingon the image acquisitionparameters characterizingthe image to be filtered.Non-automatic imagefiltering by three types ofadaptive filters and twotypes of non-adaptive fil-ters. | Unchanged |
| Networkingfunctions | Printing of images thathave been pre-formatted inDICOM3 protocol form.Sending images inDICOM3 protocol formusing TCP/IP.Sending images to othersystems of the | Printing of images thathave been pre-formatted inDICOM3 protocol form.Sending images inDICOM3 protocol formusing TCP/IP.Sending images to othersystems of the | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN M | Comments |
| ARTOSCAN-DedicatedMRI family using TCP/IPor PPP (Modem). | ARTOSCAN-DedicatedMRI family using TCP/IPor PPP (Modem). |
{8}------------------------------------------------
{9}------------------------------------------------
Patient positioning 3.
. . . .
| Characteristic | ARTOSCAN S | ARTOSCAN M | Comments |
|---|---|---|---|
| Limb fastening | All coils are especiallydesigned to keep theexamined limb in theproper position. | All coils are especiallydesigned to keep theexamined limb in theproper position. | Unchanged |
Installation Area Conditions 3.
| Characteristic | ARTOSCAN S | ARTOSCAN M | Comments |
|---|---|---|---|
| Type ofinstallation | Fixed area ("permanentlyinstalled" according to EN60601-1) | Fixed area ("permanentlyinstalled" according to EN60601-1)Mobile | Differently fromARTOSCAN M,ARTOSCAN Shas not a mobileconfiguration. |
Note: Any deviations from original ARTOSCAN M specifications are substantiated within Quality System documentation at Esaote S.p.A..
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the circumference. Inside the circle is a stylized image of a bird or eagle, represented by three curved lines that suggest feathers or wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
Colleen Hittle Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive Indianapolis, IN 46250 Re:
K981358 Artoscan S ( MRI System ) Dated: April 13, 1998 Received: April 14, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LHN
Dear Ms. Hittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Apporal), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
Indications For Use
510(k) Number (if known):
ﮨﮯ ۔ ﮨ
K 98/358
Device Name:
Artoscan S
Indications for Use:
The Artoscan S is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints 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), spinspin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use __
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981358
રેસ
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.