Product code LMB
- Device name
- Device, Digital Image Storage, Radiological
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.2010
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992131 | SAMSUNG RAYPAX LONG TERM ARCHIVE | Samsung Sds Co., Ltd. | 1999-09-13 |
| K984405 | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | 1999-02-08 |
| K983447 | WISE (II) IMAGE MANAGEMENT SYSTEM | Sectra-Imtec AB | 1998-10-29 |
| K980243 | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) | Parameter Developments, Inc. | 1998-04-03 |
| K973463 | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE | O Tech, Inc. | 1997-12-02 |
| K973413 | ID. STORE (RELEASE 2.0) | I.S.G. Technologies, Inc. | 1997-11-25 |
| K972380 | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) | Eastman Kodak Company | 1997-09-11 |
| K971848 | TDK MEDICAL GRADE CD-R | Tdk Electronics Corporation of America | 1997-08-15 |
| K971451 | WISE IMAGE MANAGEMENT SYSTEM | O Tech, Inc. | 1997-06-26 |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | Biosound, Inc. | 1997-03-31 |
| K964803 | UNIVISION ECHOCARDIOLOGY SYSTEM | Network Concepts, Inc. | 1997-02-11 |
| K964274 | WRITESTAR, AND VIEWSTAR | Comview Corp. | 1997-01-10 |
| K963395 | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM | Sectra-Imtec AB | 1996-10-25 |
| K961680 | SONY DKR-700 DIGITAL STILL RECORDER | Sony Medical Systems | 1996-07-03 |
| K961160 | UPACS VERSION 1.7 | Base Ten Systems, Inc. | 1996-06-11 |
| K960981 | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY | Kodak Health Imaging Systems, Inc. | 1996-06-07 |
| K960941 | UPACS | Base Ten Systems, Inc. | 1996-06-03 |
| K951942 | LAST IMAGE HOLD | Insight Systems | 1996-04-08 |
| K955237 | TIGERSCAN/TIGERVIEW | Tau Corp. | 1996-04-04 |
| K960326 | FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM | Fujifilm Medical System U.S.A., Inc. | 1996-03-07 |
| K952238 | VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) | Imaging Concepts, Inc. | 1996-02-21 |
| K955184 | ACCULUPE | E For M Imaging Systems Div., Marquette Electronic | 1996-01-24 |
| K955232 | NT SERIES DIGITAL IMAGE MANAGER | Camtronics, Ltd. | 1995-12-11 |
| K950630 | WALLACH DIGITAL IMAGING SYSTEM | Wallach Surgical Devices, Inc. | 1995-11-22 |
| K952888 | OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS | Olympus America, Inc. | 1995-09-18 |
| K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995-09-15 |
| K951141 | STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER | Star Technologies, Inc. | 1995-05-30 |
| K942558 | INSTACINE | Fidelity Medical, Inc. | 1995-05-30 |
| K945654 | NICOM DIGITAL IMAGE MANAGER | Camtronics, Ltd. | 1995-02-17 |
| K933115 | DIGITAL DISK RECORDER | Eigen | 1994-04-07 |
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|---|---|---|---|
| 00745426000028 | MiPACS Storage Server | Apryse Software Corp. | 2026-04-27 |
| 00850631008834 | Roentgen Works | Brit Systems, LLC | 2026-04-07 |
| 00850631008841 | Roentgen Works | Brit Systems, LLC | 2026-04-07 |
| 00850631008766 | Roentgen Works | Brit Systems, LLC | 2025-10-01 |
| 00857534006875 | IMRISmatrix 5.0 | IMRIS Imaging, Inc. | 2025-09-18 |
| 00810339031190 | SAFE DENT | BGSS Company Inc. | 2024-05-01 |
| 00810339031213 | SAFE DENT | BGSS Company Inc. | 2024-05-01 |
| 00810339031237 | SAFE DENT | BGSS Company Inc. | 2024-05-01 |
| 04250337106364 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337119852 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337106371 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337115281 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337115298 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337116165 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337117346 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337117698 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337119685 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337119821 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337119845 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337105312 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337105299 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337103950 | Vitegra® | Joimax GmbH | 2022-12-30 |
| 04250337100645 | Vitegra® | Joimax GmbH | 2022-12-30 |
| G01900 | ThinkingNet | Thinking Systems Corporation | 2020-12-11 |
| 00850631008148 | Roentgen Works | Brit Systems, LLC | 2020-01-08 |
| 00850631008124 | Roentgen Works | Brit Systems, LLC | 2019-10-11 |
| 00850631008063 | Roentgen Works | Brit Systems, LLC | 2019-06-21 |
| 00850631008025 | Roentgen Works | Brit Systems, LLC | 2019-03-29 |
| 00850631008018 | Roentgen Works | Brit Systems, LLC | 2018-12-21 |
| 00866562000236 | Standard Imaging PIPSpro Software | STANDARD IMAGING INC. | 2016-10-11 |