(77 days)
Not Found
No
The description focuses on hardware components and standard data management techniques like prefetching and hierarchical storage, with no mention of AI or ML terms or functionalities.
No
The device is described as an archival product for medical images within a PACS system, not as something that directly treats or diagnoses a medical condition.
No.
The device is described as an archival product for images within a PACS system, not as a tool for interpreting images to make a diagnosis.
No
The device description explicitly lists hardware components (host CPU, magnetic cache/RAID, CD jukebox/DLT library, 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 that the device is 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 diagnostic tests on biological samples.
- Device Description: The description details hardware components like CPUs, storage systems (RAID, CD jukebox, DLT library), and power supply. These are typical components of an image archiving system, not an IVD device which would involve components for handling and analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing chemical reactions, or providing diagnostic results based on laboratory tests.
Therefore, the KODAK DIGITAL SCIENCE Medical Image and Information Library is an image archiving system for PACS, not an In Vitro Diagnostic 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 Archiving and Sommercess to previous imagery.
INDICATION FOR USE:
DICOM conformant archival product (storage library) designed for use within a Picture Archiving and Communications System (PACS).
Product codes (comma separated list FDA assigned to the subject device)
90 LMB
Device Description
The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5, SPARCstation 20, or UltraSparc) with pre-installed proprietary software, 2) the magnetic cache, a Sun SPARC storage Redundant Array of Inexpensive Disks (RAID) subsystem, and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox or a Digital Linear Tape (DLT) library. The RAID subsystem, combined with either the CD jukebox or DLT library, 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
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
SEP 11 1997
Safety and Effectiveness Information 7.0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS X972380
- DATE PREPARED: June 23, 1996 I.
SUBMITTER: II.
Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026
CONTACT PERSON: III.
Stan E. Tillman Director, Regulatory Affairs Health Imaging Division, Dallas (972) 454-1642
- IV. DEVICE NAME:
Trade Name - KODAK DIGITAL SCIENCE™ (KDS) Medical Image and Information Library (MIL)
Common Name - PACS Storage Device (Archive)
-
V. DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750. -
VI. PREDICATE DEVICE
Kodak Digital Science Medical Image and Information Library--K960981 -
VII. DESCRIPTION OF DEVICE
The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5, SPARCstation 20, or UltraSparc) with pre-installed proprietary software, 2) the magnetic cache, a Sun SPARC storage Redundant Array of Inexpensive Disks (RAID) subsystem, and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox or a Digital Linear Tape (DLT) library. The RAID subsystem, combined with either the CD jukebox or DLT library, 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.
1
KODAK DIGITAL SCIENCE Premarket Notification
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 Archiving and Sommercess to previous imagery.
COMPARISON OF FEATURES V.
| K-number | This 510(k) | K960981 |
|---|---|---|
| Range of Storage | 12 GB - 20 TB | 8 GB to 216 GB |
| Type of Interface | SCSI | SCSI |
| Type of Media | 5.25" CD-Recordable | |
| or | ||
| Digital Linear Tape (DLT) | 5.25" CD-Recordable | |
| Jukebox, Maximum | Yes, 150-CD | |
| or | ||
| 588 DLT Cartridges | Yes, 150-CD | |
| Compression | Yes, lossless 2:1 | |
| or | ||
| lossy to 50:1 | Yes, lossless 2:1 | |
| DICOM Conformant | Yes, Native | Yes, Native |
| HIS/RIS Interface | Yes | Yes |
| Host Platform | Sun | Sun |
| Database Structure | Distributed | Distributed |
6/97
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Image /page/2/Picture/16 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
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Stan E. Tillman Director, Regulatory Affairs Eastman Kodak Company Health Imaging Division Medical Imaging Systems 18325 Waterview Parkway Dallas, Texas 75252
Re:
K972380 "Kodak Digital Science™ Medical Image Archive" Dated: June 23, 1997 Received: June 26, 1997 Regulatory class: Unclassified Procode: 90 LMB
Dear Mr. Tillman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _K9723 3 80
Device Name: Kodak Digital Science™ Medical Image and Information Library (MIIL)
INDICATION FOR USE:
ﻨﻴﻨﺘﺎ
ﺴﻴﺔ
DICOM conformant archival product (storage library) designed for use within a Picture Archiving and Communications System (PACS).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Elinil A. Segerson
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972380
2