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FDA 510(k)

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO

K-Number: K061641 · 2006-07-14

ApplicantShimadzu Medical Systems
Decision Date2006-07-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO 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 2006-07-14 under 510(k) number K061641. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO?

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO is a medical device that received FDA 510(k) clearance on 2006-07-14. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K061641.

When did ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO receive FDA 510(k) clearance?

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO received FDA 510(k) clearance on 2006-07-14, under 510(k) number K061641.

Who is the listed applicant for ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO?

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 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO?

The FDA product code for ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO is IYO.

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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: IYO)

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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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