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FDA 510(k)

SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K012253 · 2001-08-30

ApplicantAloka Co., Ltd.
Decision Date2001-08-30
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aloka Co., Ltd.. It received FDA 510(k) clearance on 2001-08-30 under 510(k) number K012253. 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 SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM?

SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-30. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K012253.

When did SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2001-08-30, under 510(k) number K012253.

Who is the listed applicant for SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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Other records listing Aloka 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.

K111227ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEMK110207ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMK093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEMK083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEMK081843ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM

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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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