Product Code: LMB FDA class 1 21 CFR 892.2010

Device, Digital Image Storage, Radiological

Radiology

Device, Digital Image Storage, Radiological provides electronic maintenance and access functions for medical images, serving as hardware-based storage infrastructure within a medical imaging system such as a PACS (Picture Archiving and Communication System). This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LMB, regulated under 21 CFR 892.2010, within the Radiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LMB
Device Class: FDA class 1
Regulation Number: 892.2010
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K992131	SAMSUNG RAYPAX LONG TERM ARCHIVE	Sep 13, 1999	Substantially Equivalent	Samsung Sds Co., Ltd.
K984405	ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000	Feb 08, 1999	Substantially Equivalent	Intracom Corp.
K983447	WISE (II) IMAGE MANAGEMENT SYSTEM	Oct 29, 1998	Substantially Equivalent	Sectra-Imtec AB
K980243	PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)	Apr 03, 1998	Substantially Equivalent	Parameter Developments, Inc.
K973463	OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE	Dec 02, 1997	Substantially Equivalent	O Tech, Inc.
K973413	ID. STORE (RELEASE 2.0)	Nov 25, 1997	Substantially Equivalent	I.S.G. Technologies, Inc.
K972380	KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)	Sep 11, 1997	Substantially Equivalent	Eastman Kodak Company
K971848	TDK MEDICAL GRADE CD-R	Aug 15, 1997	Substantially Equivalent	Tdk Electronics Corporation of America
K971451	WISE IMAGE MANAGEMENT SYSTEM	Jun 26, 1997	Substantially Equivalent	O Tech, Inc.
K963936	ACCESSPOINT, MED E-MAIL, DICOM READER	Mar 31, 1997	Substantially Equivalent	Biosound, Inc.
K964803	UNIVISION ECHOCARDIOLOGY SYSTEM	Feb 11, 1997	Substantially Equivalent	Network Concepts, Inc.
K964274	WRITESTAR, AND VIEWSTAR	Jan 10, 1997	Substantially Equivalent	Comview Corp.
K963395	IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM	Oct 25, 1996	Substantially Equivalent	Sectra-Imtec AB
K961680	SONY DKR-700 DIGITAL STILL RECORDER	Jul 03, 1996	Substantially Equivalent	Sony Medical Systems
K961160	UPACS VERSION 1.7	Jun 11, 1996	Substantially Equivalent	Base Ten Systems, Inc.
K960981	KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY	Jun 07, 1996	Substantially Equivalent	Kodak Health Imaging Systems, Inc.
K960941	UPACS	Jun 03, 1996	Substantially Equivalent	Base Ten Systems, Inc.
K951942	LAST IMAGE HOLD	Apr 08, 1996	Substantially Equivalent	Insight Systems
K955237	TIGERSCAN/TIGERVIEW	Apr 04, 1996	Substantially Equivalent	Tau Corp.
K960326	FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM	Mar 07, 1996	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K952238	VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)	Feb 21, 1996	Substantially Equivalent	Imaging Concepts, Inc.
K955184	ACCULUPE	Jan 24, 1996	Substantially Equivalent	E For M Imaging Systems Div., Marquette Electronic
K955232	NT SERIES DIGITAL IMAGE MANAGER	Dec 11, 1995	Substantially Equivalent	Camtronics, Ltd.
K950630	WALLACH DIGITAL IMAGING SYSTEM	Nov 22, 1995	Substantially Equivalent	Wallach Surgical Devices, Inc.
K952888	OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS	Sep 18, 1995	Substantially Equivalent	Olympus America, Inc.
K950279	TOMTECP90	Sep 15, 1995	Substantially Equivalent	Tomtec Imaging Systems, Inc.
K951141	STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER	May 30, 1995	Substantially Equivalent	Star Technologies, Inc.
K942558	INSTACINE	May 30, 1995	Substantially Equivalent	Fidelity Medical, Inc.
K945654	NICOM DIGITAL IMAGE MANAGER	Feb 17, 1995	Substantially Equivalent	Camtronics, Ltd.
K933115	DIGITAL DISK RECORDER	Apr 07, 1994	Substantially Equivalent	Eigen
K935498	7500 DATA TOWER	Apr 01, 1994	Substantially Equivalent	E-Systems, Inc.
K931410	NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM	Feb 18, 1994	Substantially Equivalent	Novus Technologies, Inc.
K934889	OLYMPUS IMAGEMANAGER SYSTEM	Jan 28, 1994	Substantially Equivalent	Olympus
K934888	OLYMPUS IMAGEMANAGERSYSTEM	Jan 25, 1994	Substantially Equivalent	Olympus
K926348	SC1000 SCAN CONVERTER	Nov 19, 1993	Substantially Equivalent	Perkins Mfg. Co.
K923680	ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM	Oct 20, 1992	Substantially Equivalent	Minnetonka Medical
K921275	SONY LASER VIDEODISC RECORDING SYSTEM	Jun 10, 1992	Substantially Equivalent	Sony Medical Systems
K914728	KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM	Mar 02, 1992	Substantially Equivalent	Eastman Kodak Company
K915094	VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM	Dec 27, 1991	Substantially Equivalent	Vortech Data, Inc.
K905488	DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN	Dec 18, 1991	Substantially Equivalent	Ausonics Pty , Ltd.
K903806	ANGIOTEC IMAGE MANAGEMENT SYSTEM	Nov 23, 1990	Substantially Equivalent	Andros Analyzers, Inc.
K901956	DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)	Jul 02, 1990	Substantially Equivalent	Eigen
K901118	OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM	Apr 10, 1990	Substantially Equivalent	Adac Laboratories
K891690	KODAK EKTASCAN IMAGE MANAGER	Jun 15, 1989	Substantially Equivalent	Eastman Kodak Company
K885327	PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM	May 11, 1989	Substantially Equivalent	Philips Medical Systems North America, Inc.
K891485	ANGIOTEC FMX-2220 SYSTEM	May 05, 1989	Substantially Equivalent	Andros Analyzers, Inc.
K884990	IMS-3 PICTURE ARCHIVING SYSTEM	Mar 23, 1989	Substantially Equivalent	The Biomedical Engineering Center
K884148	DISKCAM DC 6001	Nov 23, 1988	Substantially Equivalent	Camtronics, Ltd.
K882184	HR-1000 W/SUFFIXES (B,C OR D)	Jun 28, 1988	Substantially Equivalent	Eigen
K873048	KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET	Oct 30, 1987	Substantially Equivalent	Eastman Kodak Company
K863286	ERS SYSTEM	Oct 27, 1986	Substantially Equivalent	General Electric Co.
K862842	ADVANCED NUCLEAR COMPUTER	Oct 27, 1986	Substantially Equivalent	Advanced Nuclear Imaging Corp.
K844132	MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER	Jan 22, 1985	Substantially Equivalent	Sigma Teleproducts, Inc.
K843349	ND3100 VIDEO IMAGER	Dec 17, 1984	Substantially Equivalent	Nuclear Data, Inc.
K833525	CEMAX-1000	Nov 21, 1983	Substantially Equivalent	Contour Medical Systems, Inc.