(14 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard MRI technology.
No
The device is described as a "diagnostic nuclear magnetic resonance imaging" device and a "magnetic resonance diagnostic device" intended to produce images for diagnostic information, not for therapy.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "diagnostic nuclear magnetic resonance imaging" and that "If interpreted by a medical expert, these images can provide diagnostically useful information." Additionally, the "Device Description" explicitly states, "The E-scan is a magnetic resonance diagnostic device."
No
The device description explicitly states it is a "magnetic resonance diagnostic device" and mentions a "Multipurpose Flexible Receiving Coil," indicating it includes hardware components beyond just software.
Based on the provided information, the E-scan is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body. The E-scan is a magnetic resonance imaging device that directly images parts of the human body (limbs and joints). It does not analyze biological samples like blood, urine, or tissue.
- The intended use describes imaging the internal structure of limbs and joints. This is a form of medical imaging, not in vitro testing.
- The device description confirms it's a magnetic resonance diagnostic device. This further supports its classification as an imaging device.
Therefore, the E-scan falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, The E-Stan Is Inchood for dagliourist, hand, calf, thigh, arm and forearm The device Knee, ankle, foot, shoulder, cloow, wils, hand, edit, 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-latice 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)
90LNH, 90 MOS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear magnetic resonance imaging
Anatomical Site
hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summar 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: | August 6, 2001 |
| 807.92(a)(2) | |
| Trade Name: | E-Scan |
| Common Name: | Magnetic resonance diagnostic device |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification Number: | 90LNH 90 MOS |
| 807.92(a)(3) |
Predicate Device(s)
| Esaote | E-Scan K001894 |
|---|---|
| -------- | ---------------- |
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, The E-Stan Is Inchood for dagliourist, hand, calf, thigh, arm and forearm The device Knee, ankle, foot, shoulder, cloow, wils, hand, edit, 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-latice 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
The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.
2
3 Fork) Summar.
E-Sean
Biosound Esaote
| E-scan
With Multipurpose
Flexible Receiving
| Coil | Comments |
|---|---|
| Shoulder coil No.1: | |
| 17.5 x 12.6 x 14.5 cm | |
| (w x d x h) | |
| Shoulder coil No. 5: | |
| 16.8 x 7.9 x 15.5 cm | |
| (w x d x h) | |
| Multipurpose flexible coil: | |
| 22 x 32.5 x 32.5 | |
| (short axis x long axis) | The Multipurpose flexible coil substitutes |
| completely the Hip Coil. For its | |
| characteristics the flex coil can be used to | |
| exam the shoulder and the knee too, | |
| especially for patient with painful or in | |
| plaster limb. | |
| See example for the Flexible body Coil | |
| (hip and other regions) – 20x150 cm (wxd) |
- of the AIRIS HITACHI (K945155) |
Substantial Equivalence Comparison Table
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioSound Esaote, Inc. % Ms. Colleen J. Hittle The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 AUG 2 9 2001
-und Esaote, inc.
- Colleen J. Hittle
_nson Group
Castleway Drive
anolis Indiana 46250
Re: K012728 E-Scan MRI System (Receiving Coil) Dated: August 6, 2001 Received: August 15, 2001 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Ms. Hittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we device is we nave revel your section 710(s) nothedited with the enclosure) to legally marketed predicate devices marketed in interstate subsancery of the monenent to the notenent of the Medical Device Amendments, or to devices that have been reclassified in commerce with the provisions of the Federal Food, Divg, and Cosmetic Act (Act). You may, therefore, market the device, subject to ation and white 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 (Premarket Approval), it may be subject to succ If your device to classinot (coo no vegulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 800 to 07.1 A substantial.) equality System 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 Qs illsponolis, all 1 od alle Drag Pramination (Slish futher announcements concerning your device in the Federal Register. Please result it tegulatory action. In addition submission does not affect any obligation you might have under sections $31 through note: and response to your premaine 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 marked 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
(301) 594-4591 8xx.1xxx 876.2xxx, 3xxx, 4xxx, 5xxx (301) 594-4616 (301) 594-4616 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4654 892.2xxx, 3xxx, 4,xxx, 5xxx (301) 594-4692 Other
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-639. 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, 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 brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications For Use
510(k) Number (if known):
Kc/2728
Device Name:
E-Scan
Indications for Use:
The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, The E-scan is included for dagatosto nacious naments of the device produces transverse, sagittal, soronal 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 that check the naginette resoluntion properties cle depsity, 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
Nancy Choodon
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012728