(16 days)
Not Found
No
The document describes standard PACS functionalities like image transmission, storage, display, and basic processing (manipulation, enhancement, compression, quantification, MIP/MPR). There is no mention of AI, ML, deep learning, or any related terms or concepts.
No.
The device is described as software that receives, transmits, stores, and displays medical images for clinical purposes and interpretation by radiologists, and processes medical images. It does not provide any therapeutic function.
Yes
The device is intended to receive, transmit, store, and display images for clinical purposes. It enables processing of medical images from various modalities and provides functions for image manipulation and enhancement for interpretation by trained radiologists, which makes it a diagnostic device.
Yes
The device description explicitly states that vRad™ PACS is a device which consists solely of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The vRad™ PACS software is described as a system for receiving, transmitting, storing, and displaying medical images (like X-ray, CT, MRI, etc.) for clinical purposes and interpretation by radiologists. It processes and manipulates these images.
- Lack of biological sample analysis: The device does not analyze biological samples from the human body. Its input is medical images, not biological specimens.
Therefore, the vRad™ PACS software falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The vRad™ PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRad™ PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad™ PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad™ PACS Storage component. The vRad™ PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad™ PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.
The vRad™ PACS system should not be used for Mammography primary image diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
vRad™ PACS is a device which consists solely of software and allows electronic transmission of radiological patient images from one location to another. The device has the capability to accept, transfer, display, store, and digitally process medical images to trained and qualified radiologists for the purposes of providing digital diaging The software provides functions for performing operations interpretation services. related to image manipulation, enhancement, compression, and quantification of medical images (except mammography images). The software enables the user to display 3D maximum intensity projection (MIP) and Multi-Planar Reformatting (MPR) visualization of study images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified radiologists
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
§ 892.2050 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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510(k) Summary
MAR 2 7 2009
February 25, 2009 Date of Summary Preparation:
- Virtual Radiologic Corporation Submitter: 11995 Singletree Lane Suite 500 Eden Prairie, MN 55344-5349
- Company Contact: Kimberly Tokach Requiatory Compliance Manager Virtual Radiologic Corporation Manufacturer:
- 11995 Singletree Lane Suite 500 Eden Prairie, MN 55344-5349
- vRad™ Picture Archiving and Communications Device Name: System, (PACS)
- Medical Image Processing Software Common/Usual Name:
- Picture Archiving and Communications System Classification Name: LLZ Product Code: 21 CFR 892.2050 Regulation Number: Device Classification: Class II FuiiFilm Medical Systems, Synapse Workstation Predicate Devices: Software, K051553 Fuiifilm Medical Systems, Synapse Image
Visualization Software (MIP/MPR) Obliquus, K061672
Device Description:
vRad™ PACS is a device which consists solely of software and allows electronic transmission of radiological patient images from one location to another. The device has the capability to accept, transfer, display, store, and digitally process medical images to trained and qualified radiologists for the purposes of providing digital diaging The software provides functions for performing operations interpretation services. related to image manipulation, enhancement, compression, and quantification of medical images (except mammography images). The software enables the user to display 3D
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maximum intensity projection (MIP) and Multi-Planar Reformatting (MPR) visualization of study images.
Intended Use:
The vRad™ PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRad™ PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad™ PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad™ PACS Storage component. The vRad™ PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad™ PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.
The vRad™ PACS system should not be used for Mammography primary image diagnosis.
Comparison of Technological Characteristics:
The vRad™ PACS shares the same technological characteristics as the predicate devices. These characteristics include similar design, technical requirements and intended use.
Substantial Equivalence:
The vRad™ PACS is substantially equivalent to the predicate devices in design, technical requirements and intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Virtual Radiologic Corporation
MAR 2 7 2009
- % Mr. Mark Job
- Responsible Third Party Official
- Regulatory Technology Services LLC
- 1394 25th Street NW
- BUFFALO MN 55313
Re: K090649
Trade/Device Name: vRad™ Picture Archiving and Communications System (PACS) Software Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II
Product Code: LLZ
· Dated: March 10, 2009
Received: March 11, 2009
Dear Mr. Job:
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 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.
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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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding os 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.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse everts (Medical Device Reporting (MDR)), please contact the Division of Surveillanee-Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.support/index.btml.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
Current 510(k) Number:
Device Name:
vRad M1 Picture Archiving and Communications System (PACS) Software
909014
Indications for Use:
The vRad™ PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRad™ PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad™ PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad™ PACS Storage component. The vRad™ PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad™ PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.
The vRad™ PACS system should not be used for Mammography primary image diagnosis.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K090649 |