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FDA 510(k)

AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A

K-Number: K113612 · 2012-02-10

ApplicantPanasonic Healthcare Co., Ltd.
Decision Date2012-02-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A is the device name listed in this FDA 510(k) record. The listed applicant is Panasonic Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2012-02-10 under 510(k) number K113612. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A?

AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A is a medical device that received FDA 510(k) clearance on 2012-02-10. The listed applicant is Panasonic Healthcare Co., Ltd.. The 510(k) number is K113612.

When did AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A receive FDA 510(k) clearance?

AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A received FDA 510(k) clearance on 2012-02-10, under 510(k) number K113612.

Who is the listed applicant for AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A?

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

What is the FDA product code for AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A?

The FDA product code for AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A is IYN.

Related Clinical Trials

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.

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Other records listing Panasonic Healthcare Co., 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.

K122009AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCERK103148AIDA DIAGNOSTIC ULTRASOUND SYSTEM

Related Devices (Code: IYN)

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.

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Official Source

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