(81 days)
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No
The summary describes a system for storing and retrieving digital images using standard storage technologies and the DICOM protocol. There is no mention of AI, ML, or any related concepts like image processing or performance metrics typically associated with AI/ML-driven image analysis.
No
The device is used for storing and retrieving digital radiological images and communicating via the DICOM standard, which are functions related to managing medical data, not directly treating a medical condition.
No
The device stores and retrieves digital images and related information, functioning as an archive system for radiological images without performing any diagnostic analysis.
No
The device description explicitly mentions "three storage technologies; magnetic, magneto-optical and DLT tape," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary function is storing and retrieving digital images, communicating via DICOM. This is related to medical imaging data management, not the analysis of biological samples.
- Device Description: It describes a system for filing and storing radiological images. This aligns with image archiving, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on these samples to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is focused on managing existing medical images.
N/A
Intended Use / Indications for Use
The NT Archive Systems will be used to digitally store medical images for archival together with information about the images.
The Olicon Imaging Systems, NT Archive Systems stores and retrieves digital images together with information about the DICOM standard network protocol. communicates with other devices via the DICOM standard network protocol.
Product codes (comma separated list FDA assigned to the subject device)
90 LMB
Device Description
The NT ARCHIVE SYSTEM is a device for filing digital radiological images for storage and retrieval. The system design is layered with three storage technologies; magnetic, magneto-optical and DLT tape.
The NT ARCHIVE is a Microsoft Windows NT system that is basically an update of the current Olicon Archive (K922164) which is UNIX Solaris based. The NT Archive will provide a 3 tier storage system with built in backup file redundancy.
Mentions image processing
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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
Not Found
Intended User / Care Setting
The typical users are trained medial professionals.
Typical users of this system are trained professionals, including but not limited to radiologists, nurses and medical technicians.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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
Image /page/0/Picture/0 description: The image shows the logo for "OLICON IMAGING SYSTEMS, INC." The word "OLICON" is in large, bold, sans-serif font, with the letters spaced closely together. The words "IMAGING SYSTEMS, INC." are in a smaller, sans-serif font, and are located directly below "OLICON". The logo is contained within a rectangular box.
DEC - 2 1997
5 1 0(k) Summary of Safety and Effectiveness
for the Olicon Imaging Systems, Inc. NT Archive Systems
This 5 1 0(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
4 September, 1997
Submitter's Information:
Olicon Imaging Systems, Inc. 120 Columbia Avenue, Suite 600 Aliso Viejo, CA 92656 phone: (714) 360-1830 (714) 362-1522 fax:
Trade Name, Common Name, Classification:
Trade Name - Olicon Imaging Systems, Inc. ARCHIVE SYSTEMS Common Name - Digital Archive Internal Company Names - NT Archive, 02Archive, Archive,
Predicate Device:
OLICON IMAGING SYSTEMS, INC. Device: RAYTEL DIGITAL IMAGING SYSTEMS K922164 510(k) Number: 05/08/92 Date Received: 01/21/93 Decision Date: Substantially Equivalent Decision: Panel Code device reviewed by:Radiology Panel Code device classified by:Radiology LMD Product Code: Class II Classification:
1
Image /page/1/Picture/0 description: The image shows the logo for "OLICON IMAGING SYSTEMS, INC.". The word "OLICON" is in large, bold, sans-serif font. Below it, "IMAGING SYSTEMS, INC." is in a smaller, sans-serif font. The logo is black and white and is contained within a rectangular box.
510(k) Summary of Safety & Effectiveness (continued)
Device Description:
The NT ARCHIVE SYSTEM is a device for filing digital radiological images for storage and retrieval. The system design is layered with three storage technologies; magnetic, magneto-optical and DLT tape.
Indications for Use:
The NT Archive Systems will be used to digitally store medical images for archival together with information about the images. The typical users are trained medial professionals.
Technological Characteristics:
The device does not contact the patient, nor does it control any life sustaining devices. Images and information being stored and retrieved are interpreted by a physician, providing ample opportunity for competent human intervention.
The NT ARCHIVE is a Microsoft Windows NT system that is basically an update of the current Olicon Archive (K922164) which is UNIX Solaris based. The NT Archive will provide a 3 tier storage system with built in backup file redundancy.
Conclusion:
I certify that the 510(k) Pre-Market Notification for the above referenced device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to Olicon Imaging Systems, Inc. Archive Svstem - K922164.
- The NT Archive is subject to and in compliance with the Federal 1. Performance Standards, defined in 21 CFR, part 1000.
- The NT Archive has been and will be manufactured in accordance with 2. the voluntary standards listed in the enclosed voluntary standard survev.
- The submission contains the results of an hazard analysis. All potential ദ. hazards have been classified as MINOR.
Signature
Richard L. Paulsen CEO. Olicon Imaging Systems, Inc.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olicon Imaging Systems, Inc. c/o Herman Oosterwijck OTech , Inc. 6741 Grant Avenue Plano, Texas 75024
K973463 NT Archive Systems Dated: September 4, 1997 Received: September 12, 1997 Regulatory class: Unclassified Procode: 90 LMB
DEC - 2 1997
Dear Mr. Oosterwijck:
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 II (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 marketed 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
Image /page/3/Picture/0 description: The image shows the logo for "OLICON IMAGING SYSTEMS, INC." The word "OLICON" is in large, bold, sans-serif font, with each letter filled with a dotted pattern. Below "OLICON" is the text "IMAGING SYSTEMS, INC." in a smaller, bold, sans-serif font. The entire logo is contained within a black rectangular box.
510(k) Number:
Device Name: Olicon Imaging Systems, Inc. - NT Archive Systems
Indications For Use:
The Olicon Imaging Systems, NT Archive Systems stores and retrieves The Olicon Imaging Oystems, NY ... .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . digital images together with information about the DICOM standard network protocol.
communicates with other devices via the DICOM standard network protocol.
Typical users of this system are trained professionals, including but not Typical users of this, nurses and medical technicians.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
Elmer A. Sperry
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_197.340
Olicon Imaging Systems, Inc. NT Archive 510(k)