Doppler Upgrade for Ausonics Opus 1 Real Time Scan

FDA 510(k) K905488 · Ausonics Pty , Ltd.

Substantially Equivalent

510(k) numberK905488

Submission

Device name
Doppler Upgrade for Ausonics Opus 1 Real Time Scan
Applicant
Ausonics Pty , Ltd.
Washington, DC, US
Received
December 7, 1990
Decision date
December 18, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LMB – Device, Digital Image Storage, Radiological
Device class
Class I (low risk)
Regulation
21 CFR 892.2010
Specialty
Radiology

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

Other 510(k)s with product code LMB

510(k)DeviceApplicantDecision
K992131Samsung Raypax Long Term ArchiveLMB · Traditional Samsung Sds Co., Ltd.09/13/1999SE
K984405Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000LMB · Traditional Intracom Corp.02/08/1999SE
K983447Wise (II) Image Management SystemLMB · Special Sectra-Imtec AB10/29/1998SE
K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)LMB · Traditional Parameter Developments, Inc.04/03/1998SE
K973463Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveLMB · Traditional O Tech, Inc.12/02/1997SE
K973413Id. Store (Release 2.0)LMB · Traditional I.S.G. Technologies, Inc.11/25/1997SE
K972380Kodak Digital Science (KDS) Medical Image and Information Library (Miil)LMB · Traditional Eastman Kodak Company09/11/1997SE
K971848TDK Medical Grade Cd-RLMB · Traditional Tdk Electronics Corporation of America08/15/1997SE
K971451Wise Image Management SystemLMB · Traditional O Tech, Inc.06/26/1997SE
K963936Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional Biosound, Inc.03/31/1997SE

More from Biosound, Inc.

510(k)DeviceDecision
K933916Ausonics Opus 2 Realtime Ultrasound ScannerIYN · Traditional 10/03/1994SE
K915715Cine Recall Function/Opus 1 Real Time ScannerIYO · Traditional 07/02/1992SE
K920307Ausonics Opus 1 System, Annular Array OptionITX · Traditional 05/19/1992SE
K9027287.5 MHZ Bi Plane Rectal Probe (P/N: 041-815)ITX · Traditional 02/13/1991SE
K896714Ausonics 5000IYO · Traditional 06/11/1990SE
K881979Resubmittal of Mi 1000C MicroimagerJOP · Traditional 06/12/1989SE
K884299Apa-C Catalog Number A-8001-CIYO · Traditional 01/10/1989SE
K883925UroimagerIYO · Traditional 12/15/1988SE
K883079WWDS-005 Human Rectal ProbeIYO · Traditional 12/14/1988SE
K883372Alpha MC-9S Mobil C-Arm Image Intensifier UnitJAA · Traditional 11/25/1988SE

Questions and answers

When was Doppler Upgrade for Ausonics Opus 1 Real Time Scan cleared by the FDA?

Doppler Upgrade for Ausonics Opus 1 Real Time Scan (K905488) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 376 days after the submission was received.

What is the product code of K905488?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.