Atlas FDA

DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN

FDA 510(k) clearance K905488 · decided 1991-12-18

Clearance details

K-number
K905488
Device name
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
Applicant
Ausonics Pty , Ltd.
Decision
Substantially Equivalent
Date received
1990-12-07
Decision date
1991-12-18
Days to decision
376 days
Clearance type
Traditional
Product code
LMB
Device class
1
Regulation number
892.2010
Medical specialty
Radiology
Advisory committee
Radiology
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
SAMSUNG RAYPAX LONG TERM ARCHIVE (K992131)Samsung Sds Co., Ltd.1999-09-13
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (K984405)Intracom Corp.1999-02-08
WISE (II) IMAGE MANAGEMENT SYSTEM (K983447)Sectra-Imtec AB1998-10-29
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) (K980243)Parameter Developments, Inc.1998-04-03
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (K973463)O Tech, Inc.1997-12-02
ID. STORE (RELEASE 2.0) (K973413)I.S.G. Technologies, Inc.1997-11-25
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (K972380)Eastman Kodak Company1997-09-11
TDK MEDICAL GRADE CD-R (K971848)Tdk Electronics Corporation of America1997-08-15
WISE IMAGE MANAGEMENT SYSTEM (K971451)O Tech, Inc.1997-06-26
ACCESSPOINT, MED E-MAIL, DICOM READER (K963936)Biosound, Inc.1997-03-31
UNIVISION ECHOCARDIOLOGY SYSTEM (K964803)Network Concepts, Inc.1997-02-11
WRITESTAR, AND VIEWSTAR (K964274)Comview Corp.1997-01-10

Recalls involving this device

No recalls on record reference this clearance.