(76 days)
Not Found
No
The description focuses on standard image management, viewing, and communication functionalities without mentioning AI or ML.
No
The device is described as a software package for medical image management and communication, which includes acquiring, storing, transmitting, displaying, and processing medical images. Its function is to facilitate image viewing and communication, not to directly treat or diagnose a disease or condition.
No
The device is described as a software package for managing, viewing, and transmitting medical images and patient reports. Its functions center around image handling and communication, not on analyzing images to provide a medical diagnosis or assist in diagnosis.
Yes
The device description explicitly states it is a "lightly integrated package of software elements" and describes two software applications. The functions listed (acquire, store, transmit, display, viewing, communication, management, manipulation) are all software-based operations on medical images and reports. There is no mention of any 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/Indications for Use: The stated intended use is focused on the management and display of medical images and patient reports. This includes acquisition, storage, transmission, and viewing. This is characteristic of a Picture Archiving and Communication System (PACS) or a medical image viewer, not a device that performs tests on biological samples to provide diagnostic information.
- Device Description: The description reinforces this by highlighting features like a DICOM compliant viewer, 2D image viewing, and a telemedicine communication system. These are all related to handling and displaying existing medical images.
- No mention of biological samples or diagnostic testing: There is no indication that the device interacts with or analyzes biological samples (like blood, urine, tissue, etc.) to provide diagnostic results.
- Focus on image management and manipulation: The description explicitly states that "Image management and manipulation here means acquisition, archival, processing and transmission or distribution." This further emphasizes its role in handling image data, not performing diagnostic tests.
IVD devices are specifically designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is centered around the handling and display of pre-existing medical images, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
Product codes (comma separated list FDA assigned to the subject device)
90-LMD, 90-LLZ
Device Description
The ISSA™ Imaging and PHAROS Communication Products is a lightly integrated package of software elements designed to provide: DICOM compliant telemedicine viewer interface, 2D viewer of all stored medical images, Telemedicine communication system. In general terms, Issa PHAROS contains two software applications, Issa and Pharos. Both belong to the group of software produsts for medical image management and manipulations are designed to fit equaly to small medical units, such as imaging clinics or general practice clinics, and to large medical units such as hospitals or hospital departments. Image management and manipulation here means acquisition, archival, processing and transmission or distribution.
Mentions image processing
Yes
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
small medical units, such as imaging clinics or general practice clinics, and to large medical units such as hospitals or hospital departments.
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): 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).
0
510(k) Premarket Notification
Summary of Safety and Effectiveness Information
ISSA™ Imaging and PHAROS
Communication Products
1. Device Name:
| Trade Name: | ISSA PHAROS |
|---|---|
| Common Name: | Image communication and storage system |
| Classification Name: | System, Digital Image Communication Teleradiology System |
-
- Establishment Name & Registration Number: Name: VAMS TEC, D.O.O. Number: Pending
3. Classification:
Title 21, Code of Federal Regulations, § 892.2020 & § 892.2050. Now proposed exempt, final rule pendina.
ProCode: 90-LMD & 90-LLZ
4. Equivalent Device(s):
Acculmage™ Viewer Products, K961023, by Acculmage, Inc.
The referenced system is substantially equivalent to ISSA PHAROS in terms of basic design, features and intended use.
5. Description of the Device:
The ISSA™ Imaging and PHAROS Communication Products is a lightly integrated package of software elements designed to provide:
- DICOM compliant telemedicine viewer interface
- 2D viewer of all stored medical images .
- . Telemedicine communication system
In general terms, Issa PHAROS contains two software applications, Issa and Pharos. Both belong to the group of software produsts for medical image management and manipulations are designed to fit equaly to small medical units, such as imaging clinics or general practice clinics, and to large medical units such as hospitals or hospital departments. Image management and manipulation here means acquisition, archival, processing and transmission or distribution.
6. Contact Person:
Adil D Dubur, B.Sc. VAMS Tec, d.o.o Petriceva 7, 10000 ZAGREB, CROATIA 011.385.1.4872.155
7. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 VOX - 925.356.2654 FAX
1
K 9) 4054 p. 2 of 2
8. Performance Standards:
There are no applicable FDA mandated performance standards for this device. However, voluntary standards such as DICOM 3.0, and ISO/IEC 10918-1 Digital Compression and Coding of Continuous-Tone Still Images (known as JPEG) and various in-house Standard Operating Procedures and vendor qualification procedures are in place and utilized in the production of the software. The software designed to control and manipulate the diagnostic images follows the international standard (SOIIEC 12207): 1995 Information technology - Software Life Cycle Processes. In accordance with that standard, the level of concern relative to this software has been determined using the decision tree provided in Version 1 of the FDA Software Guidance.
9. Software Information:
The software described in the submission was developed, tested and validated in accordance with written Verification and Validation procedures. The software development process and the supporting procedures identify responsible individuals within VAMS Tec who develop and approve product specifications, coding and testing. No known hazardous procedures were detected during vertfication and testing that would be the consequence of software operation. Fall of the system can cause corruption of the archive. Auto-repair feature is included in the software. Archive backup intervals are adjustable by administrator from 1 day to many days.
10. Hardware Requirements: (Minimum)
- Pentium based PC 1.
- 64 MB of RAM 2.
- 4.1.GB hard disc 3.
- 24x CD-ROM র্ব
- ട്. UVGA Monitor
- MS IntelliMouse with wheel ട്.
-
- USB keyboard
- Win95/98 & Windows NT4.0. 8
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
c/o Mr. David W. Schlerf
VAMS Tec, D.o.o.
Official Correspondent Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389
FEB 1 4 2000
Re: K994054
Issa Pharos (Picture Archiving and Communications System) Dated: November 19, 1999 Received: November 30, 1999 Requiatory Class: Il 21 CFR §892.2050/Procode: 90 LLZ
Dear Mr. Schlerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/15 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is simple and iconic, representing the department's role in protecting the health of Americans.
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994054 510(k) Number (if known):
Device Name: ISSA PHAROS
Indications For Use:
Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
ISSA.DOC
510(k) Number