(67 days)
No
The document describes a standard PACS system for image storage, transfer, and display. There is no mention of AI or ML capabilities for image analysis, interpretation, or other functions.
No
The device is a Picture Archiving and Communication System (PACS) intended for the display, storage, and transfer of medical images; it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is a Picture Archiving and Communication System (PACS) intended for the acceptance, transfer, display, storage, digitization, and digital processing of medical images. It does not perform diagnostic interpretations or analyses.
Yes
The device description explicitly states that Connect Imaging PACS is a "software application" and a "complete PACS solution designed for deployment over local area networks, wide area networks, or through web access." It handles digital images and data objects within a PACS environment, receiving and distributing images. While it interacts with hardware (modalities, digitizers, workstations), the device itself is described solely as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a Picture Archiving and Communication System (PACS) for managing medical images. It focuses on the acceptance, transfer, display, storage, digitization, and digital processing of these images.
- Device Description: The description reinforces that it's a PACS software application designed for handling and distributing medical images.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is clearly intended for the management and viewing of medical images, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specification reviewed and accepted by FDA.
Connect Imaging PACS is intended for use by qualified physicians and radiologists and other trained personnel such as technologists and nurses.
Product codes
LLZ
Device Description
Connect Imaging PACS is a modified version of Connect Imaging FilmLess Clinic (K031704). Both devices are picture, archiving and communication system software applications from Connect Imaging Inc.
The main difference between the modified device and the predicate device is that the modified device will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make the viewing of these images more convenient for the user.
Both systems are a complete PACS solution designed for deployment over local area networks, wide area networks, or through web access.
Connect Imaging PACS is modular and will be offered under different brand names for different modular parts of the PACS. The Connect Imaging PACS handles various images and data objects in Picture Archiving and Communications System (PACS) environment. The Connect Imaging PACS received digital images in DICOM format from DICOM compliant modalities, as well as digitized analog images using film digitizers that are 510(k) approved. These images are stored in a central archive and distributed to various locations for viewing with an imaging workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant modalities, digitized analog images using film digitizers.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians and radiologists and other trained personnel such as technologists and nurses.
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
K061972
Connect Imaging Inc.
Page 1 of 8
510(k) Summary of Safety and Effectiveness
SEP 1 8 2006
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: June 30, 2006
Submitter's Information: 21 CFR 807.92(a)(1)
Connect Imaging Inc. Philip J. Manly, President 850 W. Hind Drive #116 Honolulu. HI 96821 Tel: 808-373-7048
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | Connect Imaging PACS |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 LLZ |
| Name: | System, Image Processing |
Predicate Device: 21 CFR 807.92(a)(3)
Device Classification Name:
Regulation Number: 510(k) Number: Device Name: Applicant: Product Code:
SYSTEM, IMAGE PROCESSING. RADIOLOGICAL 892.2050 K031704 FilmLess Clinic Connect Imaging Inc. LLZ
Device Description: 21 CFR 807.92(a)(4)
Connect Imaging PACS is a modified version of Connect Imaging FilmLess Clinic (K031704). Both devices are picture, archiving and communication system software applications from Connect Imaging Inc.
The main difference between the modified device and the predicate device is that the modified device will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make the viewing of these images more convenient for the user.
Both systems are a complete PACS solution designed for deployment over local area networks, wide area networks, or through web access.
1
Connect Imaging PACS is modular and will be offered under different brand names for different modular parts of the PACS. The Connect Imaging PACS handles various images and data objects in Picture Archiving and Communications System (PACS) environment. The Connect Imaging PACS received digital images in DICOM format from DICOM compliant modalities, as well as digitized analog images using film digitizers that are 510(k) approved. These images are stored in a central archive and distributed to various locations for viewing with an imaging workstation.
Indications for Use: 21 CFR 807.92(a)(5)
Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specification reviewed and accepted by FDA.
Connect Imaging PACS is intended for use by qualified physicians and radiologists and other trained personnel such as technologists and nurses.
Technological Characteristics: 21 CFR 807.92(a)(6)
The device is a medical device imagement and processing software that is used with computer hardware in a picture archiving and communication system user environment.
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807.92(b)(1)
The 510(k) Pre-Market Notification for Connect Imaging PACS contains adequate information and data to enable the FDA - CDRH to determine substantial equivalence to the predicate device.
2
The Connect Imaging PACS has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 1 8 2006
Mr. Philip J. Manly President Connect Imaging, Inc. 850 W. Hind Drive, #116 HONOLULU HI 96821-1855
Re: K061972
Trade/Device Name: Connect Imaging PACS Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 30, 2006 Received: July 27, 2006
Dear Mr. Manly:
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.
Image /page/3/Picture/10 description: The image is a circular seal with the letters "PA" in large, bold font in the center. Above the letters, the numbers "1876 - 1976" are arranged. Below the letters, the word "Centennial" is written in a curved manner, and there are three stars beneath it. The seal has a thick border with some text, but it is not legible.
Protecting and Promoting Public Health
4
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of devisod that I Bromination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I 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 CI IC Fart 6075; adoling (x) (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of ovisions (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) I mis letter with and in your finding of substantial equivalence of your device to a legally prematics noticated wice 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 rr you desire specific acropliance 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 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Connect Imaging Inc.
Indications for Use
Koll972 510(k) Number (if known):
Device Name: Connect Imaging PACS
Indications for Use:
Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specification reviewed and accepted by FDA.
Connect Imaging PACS is intended for use by qualified physicians and radiologists and other trained personnel such as technologists and nurses.
Prescription Use V (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)
Carolyn Y. Newland for N. Brogdon
oroductive. Abdom