(56 days)
No
The device description and intended use focus on data gateway functionality and simple image processing (rotation, reversal, decompression). There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device serves as a gateway for medical image data, performing data management and simple image processing functions, not directly involved in treating or diagnosing a medical condition.
No
Explanation: The device serves as a gateway to transfer medical image data and performs simple image processing (rotation, reversal, decompression), but it does not analyze or interpret the images to provide diagnostic information. Its function is to facilitate data communication and minor image manipulation, not to aid in diagnosis itself.
No
The device description explicitly states it consists of a computer (console, display, keyboard, and mouse) and software, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as serving as a gateway between different medical imaging networks (proprietary FCR DMS and standard DICOM). This is a data management and communication function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the device's role in connecting and transferring medical image data. It handles images from various modalities (FCR, ultrasound, CT, MRI), but it doesn't perform any analysis or testing on biological specimens.
- Image Processing: While it mentions simple image processing (rotation, reversal, decompression), this is for image display and compatibility, not for analyzing biological markers or characteristics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device's function is to facilitate the flow and management of medical images, which falls under the category of medical imaging devices or picture archiving and communication systems (PACS) components, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The indications for use of the FCR/DICOM Gateway Unit CR-DM666 is to serve as a gateway between a proprietary FCR DMS network and a standard ACR/NEMA Digital Imaging and Communications (DICOM) network.
Product codes
Not Found
Device Description
The device consists of a computer (console, display, keyboard, and mouse) and software. The device connects Fuji's proprietary Data Management System (DMS) medical image data networks complying with the American College of Radiology (ACR) and National Association of Electrical Manufacturers (NEMA) Digital Imaging and Communications in Medicine (DICOM) standard.
The Fuji network may contain Fuji Computed Radiography (FCR) image readers, workstations, optical disk files, multiformatters, and hard copy image printers. The multiformatters may receive image data from other modalities such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI).
The FCR/DICOM Gateway Unit CR-DM666 is a DICOM CR-Storage Service Class (SCU) and DICOM SC-Storage Service Class device.
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
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)
The subject and predicate devices both use standard data communications controls to detect and correct errors.
The device complies with the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.
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
Not Found
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
MAR 2 1 1997
510(k) Summary [as required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(1)]
January 13, 1997
Submitter's Information [21 CFR 807.92(a)(1)]
Fuji Medical Systems U.S.A., Inc. Post Office Box 120035 Stamford, Connecticut 06912-0035 Telephone: +1 203 973-2664 facsimile: +1 203 973-2777 Contact: Robert A. Uzenoff
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade name is Fuji Computed Radiography FCR/DICOM Gateway Unit CR-DM 666. The device common name is DICOM Gateway.
ﻨﻪ: Predicate Device [21 CFR 807.92(a)(3)]
Fuji views the subject device as an accessory to the predicate device, the Fuji FCR DMS Optical Disk Image Filing Unit OD-F6X4/L Series. FDA assigned the predicate to regulatory class II citing 21 CFR § 892.1750.
FDA's accession number for the premarket notification for the predicate device is K960326. FDA cleared the marketing of the predicate device in a letter dated March 7, 1996.
Description of the Device [21 CFR 807.92(a)(4)]
The device consists of a computer (console, display, keyboard, and mouse) and software. The device connects Fuji's proprietary Data Management System (DMS) medical image data networks complying with the American College of Radiology (ACR) and National Association of Electrical Manufacturers (NEMA) Digital Imaging and Communications in Medicine (DICOM) standard.
The Fuji network may contain Fuji Computed Radiography (FCR) image readers, workstations, optical disk files, multiformatters, and hard copy image printers. The multiformatters may receive image data from other modalities such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI).
The FCR/DICOM Gateway Unit CR-DM666 is a DICOM CR-Storage Service Class (SCU) and DICOM SC-Storage Service Class device.
1
FDA 510(k) Premarket Notification
Fuji Computed Radiography FCR/DICOM Gateway Unit CR-DM666
Intended Use [21 CFR 807.92(a)(5)]
The indications for use of the FCR/DICOM Gateway Unit CR-DM666 is to serve as a gateway between a proprietary FCR DMS network and a standard ACR/NEMA Digital Imaging and Communications (DICOM) network.
Technological Characteristics [21 CFR 807.92(a)(6)]
There device does not contact the patient, nor does it control any life sustaining devices. Images crossing the gateway are interpreted by a physician, providing ample opportunity for competent human intervention.
The subject and predicate devices are both based on an industry-standard Sun SPARC Station with 64-bit micro-SPACR II microprocessor, standard 64MB RAM, and 1.5 GB fixed magnetic disk storage. Both use a CRT for character display as part of the user interface. No image data is displayed.
Unlike the predicate, the subject device may perform simple image processing: image rotation, reversal, and the decompression of reversibly compressed (ratio: ½) image data. No compressed image data is sent to the DICOM network.
Data loss may occur because of hardware failure (e.g. hard disk crash) or operator error (e.g. turning off power during hard disk access). However, unlike the predicate, as the device is not the data source, the gateway transmission can be completed after correcting the cause of the failure. Operation is password protected to prevent unauthorized use.
Performance Data [21 CFR 807.92(b)(1)]
The subject and predicate devices both use standard data communications controls to detect and correct errors.
The device complies with the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.
Conclusion [21 CFR 807.92(b)(3)]
.
As is the case with the predicate, the subject device have no patient contact. Nor do the subject device control, monitor, or effect any devices directly connected to or effecting a patient. The images relayed by the subject devices are observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.
The device functions as a communications protocol converter, and not as a permanent image store. Device failures which might result in a failed transmission may be recovered from by retransmission after correcting the problem. Passwords are required for operation to protect against unauthorized use.
The subject and predicate share certification of conformance to the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.
We conclude that the subject devices are as safe and effective as the predicate device.