← Product Code [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB) · K973413 # ID. STORE (RELEASE 2.0) (K973413) _I.S.G. Technologies, Inc. · LMB · Nov 25, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973413 ## Device Facts - **Applicant:** I.S.G. Technologies, Inc. - **Product Code:** [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB.md) - **Decision Date:** Nov 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2010 - **Device Class:** Class 1 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Indications for Use ID.Store is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS). ## Device Story ID.Store is a PACS software component for archival storage and retrieval of digitized medical images. It utilizes a distributed storage architecture comprising three modules: ID.gate (gateway), ID.store (archiving), and ID.dbs (database manager). These modules communicate via the proprietary 'ImageTalk' protocol. The system supports various archival media including CD-R, WORM, MOD/WORM, and DVD, and operates on standard hardware such as Sun Sparc or UltraSparc CPUs with RAID for temporary storage. The software manages data flow through pre-fetching and auto-routing capabilities. It is intended for use in clinical environments where medical imaging data is processed and stored. By automating the archival and retrieval process, the device assists healthcare providers in managing large volumes of digital imaging data, ensuring lossless storage and efficient access to patient records for clinical decision-making. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Software-based PACS component. Distributed architecture using ID.gate, ID.store, and ID.dbs modules. Communication via ImageTalk protocol. Supports archival media: CD-R, WORM, MOD/WORM, DVD. Hardware requirements: Sun Sparc/UltraSparc CPUs, RAID storage. Supports DICOM and other medical imaging formats. ## 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 - Kodak Medical Image and Information Library (MIIL) ## 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 a logo with the letters "ISC" stacked vertically. Below the letters, the words "VISUAL DATA" are written in a smaller font. A partial circle is drawn around the right side of the logo. The logo is black and white. ﺴﺴﺎ | | 510(k) Summary of Safety and Effectiveness | K973413 | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Submitter: | ISG Technologies, Inc. | | | Address: | 6509 Airport Road
Mississauga, Ontario
Canada L4V 1S7 | NOV 25 1997 | | Contact: | Carol Nakagawa, Clinical Scientist | | | Telephone: | (905) 672-2100 | | | Date: | September 8, 1997 | | | Trade Name: | ID.Store | | | Common Name: | Picture Archiving and Communication System (PACS) component
software. | | | Classification Name: | PACS: Image Storage Device. | | | Predicate Device: | Kodak Medical Image and Information Library (MIIL). | | | Device Description: | The ID.Store device is a software package composed of several
application modules which work in tandem using a distributed
storage architecture to control the archival storage and retrieval of
digitized medical images. The ID.gate (gateway), ID.store
(archiving), and ID.dbs (image database manager) modules
communicate with each other using the dedicated administrative
communication protocol ImageTalk. Permanent archival storage
media supported include CD-R, WORM, MOD/WORM, DVD,
etc. Recommended hardware are standard general purpose
equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices
for temporary data storage. | | | Intended Use: | ID.Store is a software device intended to direct the lossless
archival storage and retrieval, including the use of pre-fetching and
auto-routing capabilities, of digital medical images within a Picture
Archiving and Communications System (PACS). | | | Comparison to
Predicate: | The intended use and technological characteristics of the ID.Store
device are substantially equivalent, in the opinion of ISG
Technologies, to those of the predicate device and do not pose any
additional issues of safety and effectiveness | | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 25 1997 Carol Nakagawa Clinical Scientist ISG Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 1S7 Re: K973413 ID. Store (PACS Component Software) Dated: September 8, 1997 Received: September 9, 1997 Regulatory class: Unclassified Procode: 90 LMB Dear Ms. Nakagawa: 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 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 market 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 question 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 {2}------------------------------------------------ K973413 510(k) Number (if known): Device Name: ID.Store Indications For Use: ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, 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) David C. Segner (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K973413 510(k) Number _ Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973413](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973413) **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