(106 days)
No
The summary describes a PACS accessory for image storage, routing, and display, with no mention of AI/ML terms, image processing beyond basic display, or performance studies indicative of AI/ML model evaluation.
No
This device is a software for viewing and managing medical images; it does not directly treat or diagnose a disease or condition.
No
The text explicitly states "VIEW1 Imaging ... is not recommended for primary diagnosis" and "must not be reviewed for primary image interpretations of Mammography images", indicating it is not a diagnostic device itself but rather a tool for display and review.
Yes
The device is described as "software that receives digital images and data" and "designed to provide storage, routing and display of DICOM image data through an executable program as well as in a web based format." While it uses general purpose computing hardware for display, the core functionality and the device itself are defined as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of VIEW1 Imaging clearly states it receives and displays digital images and data from existing imaging equipment. This is related to medical imaging, not the analysis of biological specimens.
- The intended use is for displaying, storing, and routing medical image data. This is the function of a PACS accessory, which is a type of medical imaging software.
- There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, VIEW1 Imaging falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIEW1 Imaging is a software that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols and is not recommended for primary diagnosis. Images and data are stored on the server in deflate image and JPEG.
VIEW1 Imaging is designed to serve as an accessory to a Picture Archiving and Communication System (PACS). It is used with general purpose computing hardware for the display of medical image data as well as patient information. It is designed to provide storage, routing and display of DICOM image data through an executable program as well as in a web based format.
VIEW1 Imaging is intended for use as a tool by trained professionals such as physicians and must not be reviewed for primary image interpretations of Mammography images.
Product codes
LLZ
Device Description
VIEW1 Imaging uses three different interfaces: HL7, DICOM and Image Generator to present, transmit and stored clinical data and digital images to physicians to be used as a review tool. It also allow physicians to access these data and images via any standard web browser-based devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, such as physicians
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)
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).
0
DEC 1 3 2011
51013 SUMMARY OF SAFETY AND EFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data.included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Global Care Quest
2151 E. Grand Ave
El Segundo, CA 90245
(424) 218-8379 |
|------------|----------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Associate Regulatory Affairs Specialist |
Device Identification:
Common Name: Soft-copy reading system
Trade Name: (optional) VIEW1 Imaging
Indications: VIEW1 Imaging is a software that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols and is not recommended for primary diagnosis. Images and data are stored on the server in deflate image and JPEG.
VIEW1 Imaging is designed to serve as an accessory to a Picture Archiving and Communication System (PACS). It is used with general purpose computing hardware for the display of medical image data as well as patient information. It is designed to provide storage, routing and display of DICOM image data through an executable program as well as in a web based format.
VIEW1 Imaging is intended for use as a tool by trained professionals such as physicians and must not be reviewed for primary image interpretations of Mammography images.
Device Description: VIEW1 Imaging uses three different interfaces: HL7, DICOM and Image Generator to present, transmit and stored clinical data and digital images to physicians to be used as a review tool. It also allow physicians to access these data and images via any standard web browser-based devices.
Substantial Equivalence: VIEW1 Imaging is substantially equivalent to IMCO-STAT (K063392). Both devices share the same indications for use and fundamental technologies, which is using DICOM 3.0 communication protocols and are able to store images in IPEG format. Both systems have the capability to provide mobile access to the information stored in the system.
1
The differences between the subject and predicate device are that the subject device also offers image compression into Deflate format, not just JPEG and it does not offer annotation or comparison of images that the predicate device offers.
Conclusion: VIEW1 Imaging is substantially equivalent to the identified predicate device and the minor differences between the subject and the predicate device do not raise any new issues of safety and efficacy.
2
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 stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Winkie Wong Associate Regulatory Affairs Specialist KARL STORZ Endoscopy America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245
DEC 1 3 2011
Re: K112480
Trade/Device Name: VIEWI Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 7, 2011 Received: December 8, 2011
Dear Ms. Wong:
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 1 . The general controls provisions of the Act include requirements for annual registration, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patil
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known): Not yet assigned
Device Name: VIEW1 Imaging
Indication for use: JVEW1 Imaging consists of software that receives digital images and data from existing imaging equipments using DICOM 3.0 communication protocols. Images and data are stored on the server in deflate compressed image and proprietary header formats. The algorithms used to create compressed images follow known and accepted protocols, such as JPEG.
VIEW1 Imaging is designed to serve as an accessory to a Picture Archiving and Communication System (PACS). It is used with general purpose computing hardware for the display of medical image data and patient information. It is designed to provide storage, routing and display of DICOM image data through an executable application as well as in a web based format.
VIEW1 Imaging is intended for use as review tool by trained professionals, such as physicians, and must not be reviewed for primary image interpretations.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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 Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112480