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FDA 510(k)

DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC

K-Number: K082224 · 2008-12-15

ApplicantShimadzu Medical Systems
Decision Date2008-12-15
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC 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 2008-12-15 under 510(k) number K082224. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC is a medical device that received FDA 510(k) clearance on 2008-12-15. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K082224.

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

DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC received FDA 510(k) clearance on 2008-12-15, under 510(k) number K082224.

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

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 DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC?

The FDA product code for DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC is ITX.

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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.

K071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PROK061641ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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