← Product Code [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB) · K973463 # OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (K973463) _O Tech, Inc. · LMB · Dec 2, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973463 ## Device Facts - **Applicant:** O Tech, Inc. - **Product Code:** [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB.md) - **Decision Date:** Dec 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2010 - **Device Class:** Class 1 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use The Olicon Imaging Systems, NT Archive Systems stores and retrieves digital images together with information about the images. The system communicates with other devices via the DICOM standard network protocol. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians. ## Device Story NT Archive System is a digital radiological image storage and retrieval device. It functions as a 3-tier storage system utilizing magnetic, magneto-optical, and DLT tape technologies. Operated by trained medical professionals (physicians, nurses, technicians) in clinical settings, the system manages digital images and associated metadata via DICOM network protocols. It serves as an archival repository for medical imaging data. The system does not contact patients or control life-sustaining equipment; all stored images require interpretation by a physician, ensuring human intervention in clinical decision-making. The device provides backup file redundancy to ensure data integrity. ## Clinical Evidence No clinical data provided. The submission relies on hazard analysis and technical comparison to the predicate device. ## Technological Characteristics 3-tier storage system (magnetic, magneto-optical, DLT tape). Platform: Microsoft Windows NT. Connectivity: DICOM standard network protocol. Device is non-patient contacting. No life-sustaining functions. Software-based archival system. ## Regulatory 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. ## Predicate Devices - Olicon Imaging Systems, Inc. Archive System ([K922164](/device/K922164.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. {2}------------------------------------------------ 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) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973463](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973463) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com