(39 days)
Not Found
No
The description focuses on basic image acquisition, manipulation (flipping, rotating, window/level, zooming, splitting), and DICOM transmission. There is no mention of AI, ML, or any advanced analytical capabilities that would suggest the use of these technologies. The performance studies described are general software testing, not validation of an AI/ML algorithm.
No
The device is a software application for acquiring, processing, and transmitting digitized film images; it does not directly treat or diagnose patients.
No
The device is described as a software application (PACS and teleradiology application) used to acquire, manage, and transmit digitized film images. It does not perform any analysis or interpretation of medical images to diagnose conditions or diseases. Its function is data handling and viewing.
No
The device description explicitly states that IMAS executes on a Microsoft Windows workstation that is connected to a film digitizer via a SCSI cable. While IMAS is a software application, its functionality is directly tied to and dependent on the film digitizer hardware for image acquisition. Therefore, it is not a software-only medical device.
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.
- IMAS Function: The description of IMAS clearly states its purpose is to acquire digitized film images, manage patient and study demographics, and transmit this information to PACS and other DICOM-compliant systems. It deals with images of the body, not samples from the body.
- Intended Use: The intended use focuses on managing and transmitting medical images for review and interpretation by healthcare professionals. It does not involve analyzing biological samples.
Therefore, IMAS falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Image Medical Acquisition Station (IMAS) is a PACS and teleradiology software application used to acquire digitized film images, add and modify patient and study demographics, and transmit the results to DICOM PACS systems, archives and workstations. IMAS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Image Medical Acquisition Station (IMAS) is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
90 LLZ
Device Description
IMAS is a software application used to acquire image data from film digitizers and send it to DICOM-compliant devices. IMAS executes on a Microsoft Windows NT, 2000 and XP workstation that is connected to a film digitizer via a SCSI cable. When IMAS initializes, it obtains some settings information from the film digitizer, and displays a user interface. From the user interface, a user logs onto IMAS using an account ID and password. Once logged into IMAS, the user has the ability to create patient and study information, instruct the film digitizer to scan one or more sheets of film and download the image data, group the data from one or more films into a folder, and send the resulting information to one or more configured destinations via DICOM.
When IMAS receives the image data from the film digitizer, it appears on the workstation monitor for review. At this point, the user can reorient the image by flipping and rotating it, adjust the window and level setting, or apply a zoom factor to it. If the digitized image is of a sheet of film containing multiple images, the user can separate the image into one or more images by defining the area of each image and creating a new image from the data in the selected area.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digitized film images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
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)
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
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
NOV -8 2004
510(k) SUMMARY KO42700
In accordance with the provisions of the Safe Medical Device Act of 1990, eRAD ImageMedical Corp., is providing a summary of safety and effectiveness information regarding the Image Medical Acquisition Station (IMAS), Picture Archiving and Communications System, digitized film acquisition software application.
-
1.1 Company Identification
ERAD/ ImageMedical Corp. 1132 W. Hamilton Street, Suite 312 Allentown, PA 18101 Establishment Registration: 2954766 Owner Operator Number: 9042966 Contact: Jim Connors, Vice President, Product Management Tel: (864) 234-7430 ext. 106 Fax: (864) 234-7412 -
1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro CA USA 94578-1116 Tel/fax: (510) 276-2648 Cell: (510) 388-5001 Email: regman10@comcast.net -
1.3 Date of Submission
September 27, 2004 -
1.4 Device Name
Classification Name: Common/Usual Name: Proprietary Name: (IMAS)
PACS Soft-copy reading and acquisition system Image Medical Acquisition Station
- । .5 Substantial Equivalence
Image Medical Acquisition Station (IMAS) software is substantially equivalent
1
to the to iCRco's Xscan32 (K002911) and Merge/eFilm's eFilm Scan (K020995
Device Description and Intended Use 1.6
IMAS is a software application used to acquire image data from film digitizers and send it to DICOM-compliant devices. IMAS executes on a Microsoft Windows NT, 2000 and XP workstation that is connected to a film digitizer via a SCSI cable. When IMAS initializes, it obtains some settings information from the film digitizer, and displays a user interface. From the user interface, a user logs onto IMAS using an account ID and password. Once logged into IMAS, the user has the ability to create patient and study information, instruct the film digitizer to scan one or more sheets of film and download the image data, group the data from one or more films into a folder, and send the resulting information to one or more configured destinations via DICOM.
When IMAS receives the image data from the film digitizer, it appears on the workstation monitor for review. At this point, the user can reorient the image by flipping and rotating it, adjust the window and level setting, or apply a zoom factor to it. If the digitized image is of a sheet of film containing multiple images, the user can separate the image into one or more images by defining the area of each image and creating a new image from the data in the selected area.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
1.7 Software Development
ERAD/ImageMedical Corp., certifies that the Image Medical Acquisition Station (IMAS) software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic quality images and associated information to the indented users.
2
Safety and Effectiveness 1.8
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and indications for use.
The hardware components specified (but not supplied) are all "off the shelt" computer components.
Validation and Effectiveness:
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
Substantial Equivalence:
IMAS has Indications for Use and a Target Population similar to other medical image devices, including iCRco's Xscan32 (K002911) and Merge/eFilm's eFilm Scan (K020995). All of the functions IMAS performs are available in at least one of the listed substantially equivalent devices. In most cases, the function is available in all of them. There are no significant differences between IMAS and the collective functions of all the predicate devices. See section E for additional information.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
ERAD Image Medical Corporation % Mr. Gary J. Allsebrook Official Correspondent Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116
· Re: K042700
Trade/Device Name: Image Medical Acquisition Station (IMAS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: September 27, 2004 Received: September 30, 2004
Dear Mr. Allesebrook:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becaled been is substantially equivalent (for the indications for use stated in above and have acteam.in arketed predicate devices marketed in interstate commerce prior to the cholosure) to regally manative processed Device Amendments, or to devices that have been May 20, 1770, the charaneneully and 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 do not require approval or a premations of the Act. The general controls provisions of the Act device, subjoct to the generation, 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 If your de rice is oldsmod (ots such additional controls. Existing major regulations affecting your Apploval), It they of casyeer 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 I least be advised mar 1271 5 issumited in 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 redular statues and regulations and listing 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) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to obgin maneering of substantial equivalence of your device to a legally premaired 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 If you desire specific advice for your ac room 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 Also, please note the regulation on your responsibilities under the Act from the 807.97). Tou may onain other general markers, and Consumer Assistance at its toll-free number (800) DVNSloll or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/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
Enclosure
5
510(k) Number (if known): 长۵५2700
eRAD/ImageMedical Corp., Image Medical Device Name: Acquisition Station (IMAS), Picture Archiving and Communications System
Indications For Use:
Image Medical Acquisition Station (IMAS) is a PACS and teleradiology software application used to acquire digitized film images, add and modify patient and study demographics, and transmit the results to DICOM PACS systems, archives and workstations. IMAS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Image Medical Acquisition Station (IMAS) is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 901.109)
OR
Over-the-Counter Use
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042700
(Optional Format 1-2-96)