(88 days)
Not Found
No
The document describes a standard PACS archival system with a prefetching algorithm, which is a common data management technique and does not inherently imply AI/ML. There are no mentions of AI, ML, or related terms like DNN, nor are there descriptions of training or test sets typically associated with AI/ML development.
No.
The "Intended Use" states that the device is an archival product for medical images and information, which is for storage and retrieval, and not for treating a condition or disease.
No
The document describes a system for archiving and retrieving medical images within a PACS, which is an archival product, not a diagnostic device.
No
The device description explicitly lists hardware components (host CPU, magnetic storage array, CD jukebox, power supply) as part of the system, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS)." This describes a system for storing and managing medical images, not for performing tests on biological samples.
- Device Description: The description details hardware components like a CPU, storage arrays (RAID and CD jukebox), and a power supply. These are typical components of a data storage and management system, not an IVD device which would involve reagents, analyzers, or other components for analyzing biological samples.
- Lack of IVD-related information: There is no mention of analyzing biological samples, performing tests, or providing diagnostic results based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device's function is to archive and retrieve medical images, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching algorithm to facilitate fast access to previous imagery.
Product codes
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Device Description
The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5 or 20) with pre-installed propriatary software, 2) the magnetic BI ARCORACIP S OF 201 orage Array RAID subsystem), and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox. The RAID subsystem and the CD jukebox are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply Provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(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
KODAK DIGITAL SCIENCE Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 7 1996
DATE PREPARED: March 4, 1996 I.
II. SUBMITTER:
Eastman Kodak Company Health Imaging Division Medical Imaging Systems 18325 Waterview Parkway Dallas, Texas 75252-8026
III. CONTACT PERSON:
Stan E. Tillman Director, Regulatory Affairs (214) 454-1642
DEVICE NAME: IV.
Trade Name - KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library (MIL) Common Name - Image Storage, Distribution, and Library
V. DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.
VI. PREDICATE DEVICE
Vortech (Kodak) Image Archive and Retrieval System -- K915094
1
KODAK DIGITAL SCIENCE Premarket Notification
VII. DESCRIPTION OF DEVICE
The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5 or 20) with pre-installed propriatary software, 2) the magnetic BI ARCORACIP S OF 201 orage Array RAID subsystem), and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox. The RAID subsystem and the CD jukebox are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply Provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.
INDICATIONS FOR USE VIII.
The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching algorithm to facilitate fast access to previous imagery.
COMPARISON OF FEATURES V.
| K-number | This 510(k) | K915094 |
|---|---|---|
| Range of Storage | 8GB to 216GB | 37GB to 1.4TB |
| Type of Interface | SCSI | SCSI |
| Type of Media | 5.25" CD-Recordable | 12" WORM Platters |
| DICOM Conformant | Yes, Native | No |
| HIS/RIS Interface | Yes | No |
| Host Platform | Sun | Sun |
| Jukebox, Maximum | Yes, 150-CD | Yes, 140-Platters |
| Compression | Yes, lossless 2:1 | Yes, lossless 2:1 |
| Database Structure | Distributed | Distributed |
SIDE-BY-SIDE COMPARISON TABLE
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