Who is the manufacturer of E-SCAN?

Biosound Esaote, Inc. filed the 510(k) submission for E-SCAN (K990968).

What is the FDA product code for E-SCAN?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for E-SCAN?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like E-SCAN?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

E-SCAN

K990968 · Biosound Esaote, Inc. · LNH · May 27, 1999 · Radiology

Device Facts

Record ID	K990968
Device Name	E-SCAN
Applicant	Biosound Esaote, Inc.
Product Code	LNH · Radiology
Decision Date	May 27, 1999
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The E-Scan 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 system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.

Device Story

E-Scan is a magnetic resonance imaging (MRI) system for limb and joint diagnostics. It captures proton density and relaxation signals (T1, T2) to generate transverse, sagittal, coronal, and oblique cross-sectional images. Operated by trained professionals in clinical settings, the device provides visual data for medical experts to interpret internal anatomical structures. Modifications from the predicate Artoscan S focus on gantry accessibility and patient comfort, alongside industrialization improvements to magnet homogeneity and RF shielding. The system aids clinical decision-making by providing non-invasive diagnostic imaging of musculoskeletal regions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Magnetic resonance diagnostic device. Features integrated RF shielding or optional shielding box. Magnet homogeneity < + 50 ppm (pk pk) on 140 mm DSV. Gradient rise time 0.8 ms (0 to 20 mT/m). Operates via nuclear magnetic resonance principles using T1, T2, proton density, flow velocity, and chemical shift parameters.

Indications for Use

Indicated for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist, and hand in patients requiring cross-sectional imaging of limbs and joints.

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

Artoscan S (K981358)

Related Devices

K020164 — E-SCAN XQ · Biosound Esaote, Inc. · Feb 12, 2002
K012728 — E-SCAN MRI SYSTEM · Biosound Esaote, Inc. · Aug 29, 2001
K032121 — MODIFICATION TO E-SCAN XQ · Esaote, S.p.A. · Aug 13, 2003
K040877 — ARTOSCAN C · Esaote, S.p.A. · May 4, 2004
K131996 — S-SCAN · Esaote, S.p.A. · Dec 13, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K990968 MAY 2 7 1999 510(k) Summary E-Scan Biosound Esaote # 510(k) Summary The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a). 807.92(a)(1) ### 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 10, 1999 | 807.92(a)(2) | Trade Name: | E-Scan | |-------------------------|--------------------------------------------| | Common Name: | Magnetic resonance diagnostic device | | Classification Name(s): | System, Nuclear Magnetic Resonance Imaging | | Classification Number: | | 807.92(a)(3) Predicate Device(s) | Esaote | Artoscan S | K981358 | |--------|------------|---------| |--------|------------|---------| Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. {1}------------------------------------------------ 510(k) Summary E-Scan Biosound Esaote #### 807.92(a)(5) #### Intended Use(s) The E-Scan 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 system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology. {2}------------------------------------------------ 510(k) Summary E-Scan Biosound Esaote | Item | Artoscan S | E-SCAN | Comments | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | # slices per echo | 1 - 128 | 1 – 96 | | | Homogeneity | < + 30 ppm on 120 mm DSV | < + 50 ppm (pk pk) on 140 mm DSV | Final result allows to enlarge the Field of View | | Fringe field (0,5 mT line) | 0,5 mT line: 140 cm from the center of the magnet X axis: 140 cm front; 90 cm rear; Y axis: 120 cm right/left; Z axis: 90 cm top/bottom | 0,5 mT line: 150 cm from the center of the magnet X axis: 150 cm front, 120 rear; Y axis: 130 cm right/left Z axis: 150 cm top/bottom | Variations due to the industrialization of the magnet | | RF Shielding | Self contained RF shielding (up to 30 dBμV/m) External shielding (up to 100 dBμV/m) | Integrated RF shielding (up to 30 dBμV/m) Shielding Box (up to 60 dBμV/m) External shielding (up to 100 dBμV/m) | The term "integrated" represents better the concept than "self- contained" A shielding box has been added as intermediate solution, in terms of both performances and costs, between the integrated RF shielding and the traditional RF cage (as this | | | | | latter is always possible but more expensive). | | Gradients' rise time | 0.5 ms from 0 to 20 mT or from -20 to 0 mT | 0.8 ms from 0 to 20 mT/m from 0 to 99% | More precise characterization of the data | | Sequences | | The sequence preliminary indicated as GEFS has been renamed into GE- STIR | | | Item | Artoscan S | E-SCAN | Comments | | Anatomical regions | Limbs: in particular Hip, Knee, Leg, Ankle, Foot, Hand, Wrist, Forearm, Elbow and Shoulder | Limbs: in particular Hip, Knee, Leg, Ankle, Foot, Hand, Wrist, Forearm, Elbow, Arm and Shoulder | It was possible to examine arms also before but it was necessary to select Other and to introduce the Arm data. Now arm is included in the standard and most common districts to be examined with E-scan | | Installation area | 3.7 x 3.7 sq. m. | Integrated shielding: 3.7 x 4 mt Shielding box: 4 x 4.5 sq. m. (min height 2.4 m) | Variation due to the industrialization of the system. | ### Comparison Chart for Substantial Equivalence {3}------------------------------------------------ 510(k) Summary E-Scan Biosound Esaote ## Comparison Chart for Substantial Equivalence Continued . {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 27 1099 Colleen Hittle Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive Indianapolis, Indiana 46250 RE: K990968 E-Scan Magnetic Resonance Diagnostic Device Dated: March 19, 1999 Received: March 23, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH 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 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). 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 Approval), 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 (21 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 requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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/dsma/dsmamain.html". Sincerely yours, CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications For Use 510(k) Number (if known): K 99 0968 Device Name: E-Scan Indications for Use: The E-Scan 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), 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. The system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ✓ OR Over-The-Counter Use David U. Bergman (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological I 510(k) Number