(34 days)
Not Found
No
The summary describes a standard PACS system for image management and viewing, with no mention of AI, ML, or advanced processing beyond basic DICOM image handling.
No
The device is an imaging software system used to acquire, transmit, store, view, and process DICOM images, which are diagnostic rather than therapeutic.
No
Explanation: The device is an imaging software system used to acquire, transmit, store, view, and process DICOM images. It mentions image processing and the intended use is by trained healthcare professionals, but it does not state that it is used to diagnose diseases or conditions. Its purpose is to manage and view existing images, not to perform diagnostic analysis itself.
Yes
The device description explicitly states that the ALZ Web PACS consists of "the ALZ Web PACS software application installed on a server and the ALZ Web PACS viewer running on client computers". It also mentions it is used with "general purpose computing hardware", implying the software is the regulated component, not the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "imaging software system" used to "acquire, transmit, store, view, and process DICOM images." This describes a system for managing and interacting with medical images, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description focuses on software for managing and viewing DICOM images, installed on servers and accessed by client computers. This aligns with a medical imaging system, not an IVD.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in biological samples
- Providing diagnostic information based on laboratory tests
IVDs are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is centered around the management and viewing of medical images, which are generated by imaging modalities (like X-ray, CT, MRI, etc.), not from biological samples.
N/A
Intended Use / Indications for Use
The ALZ Web PACS (Version 1.0) is an imaging software system intended to be used by trained healthcare professionals. The ALZ Web PACS is used with general purpose computing hardware to acquire, transmit, store, view, and process DICOM images.
This device is not intended for mammography.
Product codes
LLZ
Device Description
The ALZ Web PACS (Version 1.0) is designed for the management, viewing, and processing of DICOM images. The ALZ Web PACS consists of the ALZ Web PACS software application installed on a server and the ALZ Web PACS viewer running on client computers connecting to the server via the HTTPS protocol.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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)
The ALZ Wcb PACS was tested to verify that the device meets prospectively defined design and performance specifications. The results of the testing confirmed that the ALZ Web PACS performed as intended.
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
510(k) Summary ALZ, Inc. ALZ Web PACS (Version 1.0)
JUN 1 1 2008
COMPANY NAME AND ADDRESS 1.
ALZ, Inc. 18207 Cedar Island Blvd. Brownstown , MI 48174
| Contact: | Nasser Al Zawawi |
|---|---|
| Phone: | 313-887-9345 |
| Fax: | 888-467-1853 |
2. DEVICE NAME
| Proprietary Name: | ALZ Web PACS (Version 1.0) |
|---|---|
| Common/Usual Name: | PACS |
| Device | System, image processing, radiological |
| Classification Name: | Picture archiving and communication system |
| Product Code | LLZ |
| 21 CFR Regulation | 892.2050 |
3. PREDICATE DEVICE
- eFILM Workstation with Modules, K020995, Merge eMED, Inc. .
- UniPACS, K023476, Universal PACS, Inc. .
DEVICE DESCRIPTION 4.
The ALZ Web PACS (Version 1.0) is designed for the management, viewing, and processing of DICOM images. The ALZ Web PACS consists of the ALZ Web PACS software application installed on a server and the ALZ Web PACS viewer running on client computers connecting to the server via the HTTPS protocol.
1
5. INTENDED USE
The ALZ Web PACS (Version 1.0) is an imaging software system intended to be used by trained healthcare professionals. The ALZ Web PACS is used with general purpose computing hardware to acquire, transmit, store, view, and process DICOM images.
This device is not intended for mammography
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Both the proposed and predicate devices are software devices used with general purpose computing hardware to acquire, transmit, store, view, and process medical images. Both the proposed and predicate devices consist of a software application that is installed on a server that communicates with client PCs that connect via a TCP/IP (HTTPS for ALZ client/application server communication and DICOM Protocol for communication between the ALZ application server and other DICOM compliant devices). Basic file acquisition, storage, and sending functions, as well as image viewing and manipulation are shared by both the proposed and predicate software programs.
7. PERFORMANCE TESTING
The ALZ Wcb PACS was tested to verify that the device meets prospectively defined design and performance specifications. The results of the testing confirmed that the ALZ Web PACS performed as intended.
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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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2008
ALZ, Inc. % Ms. Cindy Nolte Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K081304
Trade/Device Name: ALZ Web PACS (Version 1.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 7, 2008 Received: May 8, 2008
Dear Ms. Nolte:
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.
3
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 (OS) 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 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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
(24)
Enclosure
4
Indications for Use
510(k) Number: K081304
ALZ Web PACS (Version 1.0) Device Name:
Indications For Use:
ALZ Web PACS (Version 1.0) is an imaging software system intended to be used by trained healthcare professionals. ALZ Web PACS is used with general purpose computing hardware to acquire, transmit, store, view, and process DICOM images.
This device is not intended for mammography.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Lopui Ph. Whang
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _