Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.2010](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2010) → LMB — Device, Digital Image Storage, Radiological # LMB · Device, Digital Image Storage, Radiological _Radiology · 21 CFR 892.2010 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB ## Overview - **Product Code:** LMB - **Device Name:** Device, Digital Image Storage, Radiological - **Regulation:** [21 CFR 892.2010](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2010) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) ## 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. ## Classification Rationale 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. ## Recent Cleared Devices (20 of 55) Showing 20 most recent of 55 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K992131](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K992131.md) | SAMSUNG RAYPAX LONG TERM ARCHIVE | Samsung Sds Co., Ltd. | Sep 13, 1999 | SESE | | [K984405](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K984405.md) | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | Feb 8, 1999 | SESE | | [K983447](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K983447.md) | WISE (II) IMAGE MANAGEMENT SYSTEM | Sectra-Imtec AB | Oct 29, 1998 | SESE | | [K980243](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K980243.md) | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) | Parameter Developments, Inc. | Apr 3, 1998 | SESE | | [K973463](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973463.md) | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE | O Tech, Inc. | Dec 2, 1997 | SESE | | [K973413](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K973413.md) | ID. STORE (RELEASE 2.0) | I.S.G. Technologies, Inc. | Nov 25, 1997 | SESE | | [K972380](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K972380.md) | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) | Eastman Kodak Company | Sep 11, 1997 | SESE | | [K971848](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K971848.md) | TDK MEDICAL GRADE CD-R | Tdk Electronics Corporation of America | Aug 15, 1997 | SESE | | [K971451](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K971451.md) | WISE IMAGE MANAGEMENT SYSTEM | O Tech, Inc. | Jun 26, 1997 | SESE | | [K963936](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K963936.md) | ACCESSPOINT, MED E-MAIL, DICOM READER | Biosound, Inc. | Mar 31, 1997 | SESE | | [K964803](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K964803.md) | UNIVISION ECHOCARDIOLOGY SYSTEM | Network Concepts, Inc. | Feb 11, 1997 | SESE | | [K964274](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K964274.md) | WRITESTAR, AND VIEWSTAR | Comview Corp. | Jan 10, 1997 | SESE | | [K963395](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K963395.md) | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM | Sectra-Imtec AB | Oct 25, 1996 | SESE | | [K961680](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K961680.md) | SONY DKR-700 DIGITAL STILL RECORDER | Sony Medical Systems | Jul 3, 1996 | SESE | | [K961160](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K961160.md) | UPACS VERSION 1.7 | Base Ten Systems, Inc. | Jun 11, 1996 | SESE | | [K960981](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K960981.md) | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY | Kodak Health Imaging Systems, Inc. | Jun 7, 1996 | SESE | | [K960941](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K960941.md) | UPACS | Base Ten Systems, Inc. | Jun 3, 1996 | SESE | | [K951942](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K951942.md) | LAST IMAGE HOLD | Insight Systems | Apr 8, 1996 | SESE | | [K955237](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K955237.md) | TIGERSCAN/TIGERVIEW | Tau Corp. | Apr 4, 1996 | SESE | | [K960326](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K960326.md) | FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM | Fujifilm Medical System U.S.A., Inc. | Mar 7, 1996 | SESE | ## Top Applicants - Eastman Kodak Company — 4 clearances - Eigen — 3 clearances - Camtronics, Ltd. — 3 clearances - Sony Medical Systems — 2 clearances - Sectra-Imtec AB — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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