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FDA 510(k)

RT55 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K953752 · 1996-03-15

ApplicantGeneral Electric Co.
Decision Date1996-03-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RT55 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K953752. 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 RT55 DIAGNOSTIC ULTRASOUND SYSTEM?

RT55 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is General Electric Co.. The 510(k) number is K953752.

When did RT55 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

RT55 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1996-03-15, under 510(k) number K953752.

Who is the listed applicant for RT55 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT55 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for RT55 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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Other records listing General Electric Co. 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.

K103489GE VEO RECONSTRUCTION OPTIONK082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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