(26 days)
No
The summary describes a standard MRI system and does not mention any AI or ML capabilities in the intended use, device description, or specific sections for AI/ML information.
No
The device is described as being "intended for diagnostic nuclear magnetic resonance imaging" and used to "provide diagnostically useful information," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic nuclear magnetic resonance imaging" and that the images produced "can provide diagnostically useful information" when interpreted by a medical expert.
No
The device description explicitly refers to an "E-Scan MRI system" and mentions a "Hip Coil" in the predicate devices, indicating it is a hardware system for nuclear magnetic resonance imaging, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- E-scan XQ Function: The E-scan XQ is an MRI system. It uses nuclear magnetic resonance imaging to produce images of internal body structures directly within the patient's body. It does not analyze specimens taken from the body.
The description clearly states it's for "diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm" and produces "cross-sectional images, displaying the internal structure of the limbs and joints being imaged." This is a form of in vivo (within the living body) diagnostic imaging, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral 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.
Product codes
90LNH
Device Description
The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.
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 and forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K963262, K990968, K001894, K012728
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
FEB 1 2 2002
510(k) Summary E-Scan × 9 Biosound Esaote
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
807.92(a)(1)
Submitter Information
| Colleen Densmore, Official Correspondent | ||
|---|---|---|
| 8000 Castleway Drive | ||
| Indianapolis, IN 46250 | ||
| Phone: | (317) 849-1916 | |
| Facsimile: | (317) 577-9070 | |
| Contact Person: | Colleen Densmore | |
| Date: | January 4, 2002 | |
| 807.92(a)(2) | ||
| Trade Name: | E-Scan XQ | |
| Common Name: | Magnetic resonance diagnostic device | |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging | |
| Classification Number: | 90LNH | |
| 807.92(a)(3) | ||
| Predicate Device(s) | ||
| Esaote | Artoscan M | K963262 |
| Esaote | E-Scan | K990968 |
| Esaote | E-Scan | K001894 |
| Esaote | Hip Coil | K012728 |
1
807.92(a)(5)
Intended Use(s)
XQ The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. 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.
807.92(a)(6)
Technological Characteristics
$\mathbb{Q}$
The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the logo is a symbol that resembles three stylized, curved lines, possibly representing a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Esaote, S.P.A. % Ms. Colleen J. Densmore Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Re: K020164
Trade/Device Name: E-Scan XQ MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 4, 2002 Received: January 17, 2002
Dear Ms. Densmore:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 nredicate 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), please If you dosho specific at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on by receibled to premainter the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Hogdin
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
KO 20164
Device Name:
E-Scan XQ
Indications for Use:
The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral 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.
(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
Norris Burleson
(Division Sign-O)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K20264