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FDA 510(k)

DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN

K-Number: K905488 · 1991-12-18

ApplicantAusonics Pty , Ltd.
Decision Date1991-12-18
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Ausonics Pty , Ltd.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K905488. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN?

DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K905488.

When did DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN receive FDA 510(k) clearance?

DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN received FDA 510(k) clearance on 1991-12-18, under 510(k) number K905488.

Who is the listed applicant for DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN?

The FDA 510(k) record lists Ausonics Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN?

The FDA product code for DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN is LMB.

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Other records listing Ausonics Pty , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933916AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNERK915715CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNERK920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTIONK9027287.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)K896714AUSONICS 5000K881979RESUBMITTAL OF MI 1000C MICROIMAGER

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Related Devices (Code: LMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec ABK980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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