(10 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on standard image viewing and manipulation functionalities.
No
The device is described as an image management device for viewing, manipulating, and analyzing medical images to aid in diagnosis and reporting, not for treating or curing a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids a cardiologist or radiologist in their diagnosis.
Yes
The description focuses entirely on software functionalities (viewing, manipulating, analyzing, reporting DICOM images) and explicitly states it is a "software package" in the predicate device, with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SView 1.0 is for "viewing, manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM-compliant imaging devices." It aids a cardiologist or radiologist in their diagnosis by providing tools for image review and analysis.
- Device Description: The description reinforces this by stating it's a "tool for 2D (two-dimensional) viewing and manipulation of DICOM compliant MR images and other DICOM-compliant images."
- Nature of IVDs: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They perform tests outside of the body.
- SView's Function: SView 1.0 works with medical images, which are generated from the body (in this case, via MRI and other imaging modalities), but it doesn't perform tests on biological specimens. It's a tool for interpreting existing image data.
Therefore, SView 1.0 falls under the category of medical image management and viewing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SView 1.0 is a medical image management device intended for viewing. manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and reviewing of patient studies.
Product codes
LLZ/892.2050
Device Description
SView " 1.0 is a tool for 2D (two-dimensional) viewing and manipulation of DICOM compliant MR images and other DICOM-compliant images. The proposed device provides real-time image viewing, manipulation, analysis and reporting.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI scanners and other DICOM -compliant imaging devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiologist or radiologist
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)
SView 1.0 is intended for use with existing MRI images for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition it facilitates the physician's reporting and reviewing of patient studies. The SView™ medical image management device contains no image digitizers and uses only lossless compression. On this basis, MRI Cardiac Services, Inc. believes that clinical investigation is not necessary.
Extensive testing of the device will be performed by programmers, by nonprogrammers, quality assurance staff and by potential customers prior to commercial release.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AccuView Diagnostic Imaging Workstation Software Package (K990241)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Ko60840 MRI Cardiac Services, Inc. 510(k) Summary
Submitter:
MRI Cardiac Services, Inc. 8 West Third Street, M9 Winston-Salem, NC 27101 336-831-1908 (v) 336-727-0919 (f)
7 2006 APR
Date Prepared:
June 1, 2004
Contact Person(s):
Scott Huber, President 336-831-1908 (v) 336-727-0919 (f)
Device Trade Name: SView™
Device Common Name:
PACS / Medical Image Management Device
Classification Name:
Class II - System, Image Processing
Product Code/Regulation Number:
LLZ/892.2050
Substantially Equivalent To:
AccuView Diagnostic Imaging Workstation Software Package (K990241) AccuImage Diagnostics Corporation 400 Oyster Point Boulevard, Suite 114 S. San Francisco, CA 94080
Device Description:
SView " 1.0 is a tool for 2D (two-dimensional) viewing and manipulation of DICOM compliant MR images and other DICOM-compliant images. The proposed device provides real-time image viewing, manipulation, analysis and reporting.
Indications for Use:
SView 1.0 is a medical image management device intended for viewing. manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and
8 West Third Street, Suite M9 Winston-Salem, NC 27101 (t)336-831-1908 (f) 336-727-0919 (e) info@mricardiovascular.com
1
MRI Cardiac Services, Inc.
reviewing of patient studies.
Technological Comparison to Predicate Device:
The proposed and predicate medical image management devices are both devices that can be used for manipulation of DICOM-compliant MR images. The proposed and predicate device can be operated from a personal computer. SView™ 1.0 and a standard Windows operating system. SView is a subset of the AccuView Diagnostic Imaging Workstation features with an optional added monitor to allow a Cardiologist or Radiologist the convenience of using two monitors, one for image viewing and manipulation, and the other for reporting. SView™ 1.0 has substantially equivalent features and specifications versus the existing AccuView Diagnostic Imaging Workstation for those features and specifications the two devices have in common.
Laboratory and Clinical Testing
SView 1.0 is intended for use with existing MRI images for real-time image viewing, image manipulation, and analysis that aid a cardiologist or radiologist in their diagnosis. In addition it facilitates the physician's reporting and reviewing of patient studies. The SView™ medical image management device contains no image digitizers and uses only lossless compression. On this basis, MRI Cardiac Services, Inc. believes that clinical investigation is not necessary.
Extensive testing of the device will be performed by programmers, by nonprogrammers, quality assurance staff and by potential customers prior to commercial release.
Adverse Effects on Health:
The potential hazards are identified in the Hazard Analysis and are controlled by:
- Designing controls directed at the cause and/or
- Introducing protective measures and/or
- o Warning the Users
All identified hazards are mitigated to minor level of concern.
See Summary of Safety and Effectiveness on the following page.
Conclusions:
We conclude that the subject device, SView™ 1.0 is as safe and effective as the predicate device and posses no new questions of safety and effectiveness. SView 114 1.0 performs in accordance with its intended use as well as the AccuView Diagnostic Imaging device currently on the market. MRI Cardiac Services, Inc. considers features of the SView™ 1.0 to be substantially equivalent to the subset of features in common with the AccuView. Diagnostic Imaging device (510(k)990241.)
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its back, representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MRI Cardiac Services, Inc. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K060840 Trade/Device Name: SView™ Version 1.0 PACS Medical Image Management Device Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: LLZ Dated: March 27, 2006 Received: March 28, 2006
Dear Mr. Lehtonen:
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 (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 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 (2) CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
APR 7 2006
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industrv/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nanev C. Broudon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
501(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: SView™ Version 1.0 PACS/Medical Image Management Device
Indications For Use:
SView 1.0 is a medical image management device intended for viewing, manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM -compliant imaging devices. SView™ 1.0 can be used for real-time image viewing, manipulation and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and reviewing of patient studies.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over- The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive. Ab and Radiological Devices 510(k) Number
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