(78 days)
Not Found
No
The summary describes a system for storing and displaying digital images from DICOM media, focusing on hardware components and data management. There is no mention of AI, ML, image processing, or performance studies related to algorithmic analysis of images.
No.
The device is described as a system for storing and displaying digital images, not for treating or diagnosing medical conditions.
No
The device is used for storing and displaying digital images, which are functions related to image management and review, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components (Cardiac Review Station, Archive Manager, DLT Drive, Automatic Tape Library, RAID, ATM Switch) in addition to the software functionality.
Based on the provided information, DicomNet is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely focused on storing and displaying digital images acquired from digital imaging systems. This is a function related to medical imaging data management and visualization, not the analysis of biological samples or the diagnosis of diseases based on in vitro tests.
- Device Description: The components listed (Cardiac Review Station, Archive Manager, storage devices, network components) are typical of a medical image management and review system. They are not components used for performing in vitro diagnostic tests.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
DicomNet appears to be a Picture Archiving and Communication System (PACS) or a similar medical image management system. These systems are regulated as medical devices, but not as IVDs.
N/A
Intended Use / Indications for Use
DicomNet is intended to be used for storing and displaying digital images acquired and stored by digital imaging systems on DICOM interchange media. DicomNet reviews images directly from the DICOM storage media (CD-Recordable disks) and can store the images in an archive manager for review on any of the network review stations. The system stores unaltered/uncompressed computer digital data.
Product codes
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Device Description
DicomNet is composed of the following:
Cardiac Review Station: A Power PC or Pentium based cpu review station capable of playback and annotation of images recalled from archival storage or read directly from MO disk.
Archive Manager: A workstation file server that provides management functions to the patient image database. The archive manager uses either the Metior HFM (Hierarchical File Manager) from Automated Network Technologies or the LSC HFM from Large Storage Configurations Inc.
DLT Drive: A high density, high speed, random access 1/2 inch tape archive providing real-time storage and retrieval of digital images.
Automatic Tape Library: A robotic tape library incorporating at least 1 but as many as 4 DLT drives that can be configured to store tens of thousands of patients on-line.
RAID: Redundant Array of Inexpensive Disks: Provides on-line storage of tens of patients, used for staging images from and to robotic tape library.
ATM Switch: (Asynchronous Transmission Mode) switch is a high performance network router that allows multimegabit per second transmission (point to point) from any peripheral in the network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital imaging systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
જી નિર્મર
510(k) Summary
Identification of the Product
JUL - 3 1996
| Trade Name: | DicomNet |
|---|---|
| Common Name: | Unknown |
| Classification Name: | Angiographic X-Ray System (accessory) |
| Manufacturer: | Lockheed Martin
Communication Systems
1 Federal Street (A&E 1C)
Camden, NJ 08103
(609) 338-3331
(609) 338-2940 (fax) |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person: Vincent J. Napoleon
Date Prepared: 01 April 1996
Indications for Use:
DicomNet is intended to be used for storing and displaying digital images acquired and stored by digital imaging systems on DICOM interchange media. DicomNet reviews images directly from the DICOM storage media (CD-Recordable disks) and can store the images in an archive manager for review on any of the network review stations. The system stores unaltered/uncompressed computer digital data.
Device Descriptions:
DicomNet is composed of the following:
Cardiac Review Station: A Power PC or Pentium based cpu review station capable of playback and annotation of images recalled from archival storage or read directly from MO disk.
Archive Manager: A workstation file server that provides management functions to the patient image database. The archive manager uses either the Metior HFM (Hierarchical File Manager) from Automated Network Technologies or the LSC HFM from Large Storage Configurations Inc.
DLT Drive: A high density, high speed, random access 1/2 inch tape archive providing real-time storage and retrieval of digital images.
Automatic Tape Library: A robotic tape library incorporating at least 1 but as many as 4 DLT drives that can be configured to store tens of thousands of patients on-line.
1
RAID: Redundant Array of Inexpensive Disks: Provides on-line storage of tens of patients, used for staging images from and to robotic tape library.
ATM Switch: (Asynchronous Transmission Mode) switch is a high performance network router that allows multimegabit per second transmission (point to point) from any peripheral in the network.
Marketing History
In the opinion of Lockheed Martin, DicomNet is comparable and substantially equivalent to the following device:
Model
Manufacturer
GE Medical Systems GEMnet (K943355)
The essential difference between DicomNet and GEMnet is DicomNet reads DICOM images from MO disks for network and archival while GEMnet formats directly from the digital acquisition system.
Potential Adverse Effects on Health
The potential concerns are controlled by:
Failure Mode and Effects Analysis (FMEA) to identify required controls Validation of the calculation models by phantoms Adherence to industry standards (UL)
Conclusions
The principles of operation of DicomNet are almost identical to the currently marketed product GEMnet. this system poses no added risk of safety.