(60 days)
No
The description focuses on network connectivity, protocol conversion, and simple image processing (rotation, reversal, decompression). There is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No.
The device's intended use is to connect imaging modalities to a hard copy system for output, performing protocol conversion and simple image processing. It is not designed to diagnose, treat, or prevent disease, which are characteristic functions of a therapeutic device.
No
The device is described as a medical imager that produces hard copies of images from various modalities. It performs tasks like protocol conversion and basic image processing (rotation, reversal, decompression) for printing, but it does not analyze or interpret medical images to diagnose conditions or assist in diagnosis. Its function is to facilitate hard copy output of images, not to derive diagnostic information from them.
No
The device description explicitly states that the device consists of a computer (console, display, keyboard, and software), indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect imaging modalities to a hard copy system for printing. This is a function related to image management and output, not the analysis of biological samples or the diagnosis of diseases based on in vitro testing.
- Device Description: The device acts as a print server, converting image data protocols for printing. It handles image data from modalities like CT, MR, NM, and US, which are in vivo imaging techniques, not in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device's function is primarily related to the handling and output of medical images acquired through in vivo methods.
N/A
The following key information is extracted from the FDA summary
Intended Use / Indications for Use
The indication for use of the Fuji Medical Laser Imager MF-PS667 is to connect imaging modalities on a network to a hard copy system for hard copy output.
Product codes
Not Found
Device Description
The device consists of a computer (console, display, kevboard, and software. The device connects a DICOM or Toshiba medical image data network to Fuji hard copy printing systems.
The network typically carries images from modalities (e.g. CT, MR, NM, or US) or other image sources being transported under DICOM or Toshiba network protocol. The print server accepts the image data, performs protocol conversion to Fuji's protocol, and passes it to Fuji's hard copy print system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
CT, MR, NM, or US
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 IEEE802,3 standard transceiver for Ethernet connection is employed. 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)
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
MAR 3 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 Robert A. Uzenoff Contact:
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade name is Fuji Medical Laser Imager MF Print Server MF-PS667.
The device common name is Print Server, Network Print Server.
Predicate Device [21 CFR 807.92(a)(3)]
Fuji identifies the subject device as an accessory to the predicate device, the Fuji Medical Laser Imager Multi-Formatters MF-300 and MF-300L. FDA assigned the predicate to regulatory class II citing 21 CFR § 892.1000 (magnetic resonance diagnostic device).
FDA's accession number for the premarket notification for the predicate device is K950721. FDA cleared the marketing of the predicate device in a letter dated May 24, 1995.
Description of the Device [21 CFR 807.92(a)(4)]
The device consists of a computer (console, display, kevboard, and software. The device connects a DICOM or Toshiba medical image data network to Fuji hard copy printing systems.
The network typically carries images from modalities (e.g. CT, MR, NM, or US) or other image sources being transported under DICOM or Toshiba network protocol. The print server accepts the image data, performs protocol conversion to Fuji's protocol, and passes it to Fuji's hard copy print system.
Intended Use [21 CFR 807.92(a)(5)]
The indication for use of the Fuji Medical Laser Imager MF-PS667 is to connect imaging modalities on a network to a hard copy system for hard copy output.
1
Technological Characteristics [21 CFR 807.92(a)(6)]
The device does not contact the patient, nor does it control any life sustaining devices. Images crossing the print serve 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, the device is a data source or image archive, 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 IEEE802,3 standard transceiver for Ethernet connection is employed. 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 DICOM standard communications protocol converter, and not as a permanent image store. Standard communications error detection and correction methods are employed. Standard network interface connections are employed. 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.