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FDA 510(k)

SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT

K-Number: K910426 · 1991-06-06

ApplicantShimadzu Medical Systems
Decision Date1991-06-06
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1991-06-06 under 510(k) number K910426. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT?

SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT is a medical device that received FDA 510(k) clearance on 1991-06-06. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K910426.

When did SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT receive FDA 510(k) clearance?

SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT received FDA 510(k) clearance on 1991-06-06, under 510(k) number K910426.

Who is the listed applicant for SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT?

The FDA 510(k) record lists Shimadzu Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT?

The FDA product code for SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT is HEM.

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Other records listing Shimadzu Medical Systems 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.

K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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Related Devices (Code: HEM)

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.

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology LabsK942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.K905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, Inc.K890637EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGEElscint, 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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