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FDA 510(k)

SONATA 3-D IMAGING ACCESSORY, MODEL 3DS

K-Number: K042620 · 2004-12-23

ApplicantTetrad Corp.
Decision Date2004-12-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONATA 3-D IMAGING ACCESSORY, MODEL 3DS is the device name listed in this FDA 510(k) record. The listed applicant is Tetrad Corp.. It received FDA 510(k) clearance on 2004-12-23 under 510(k) number K042620. 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 SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

SONATA 3-D IMAGING ACCESSORY, MODEL 3DS is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Tetrad Corp.. The 510(k) number is K042620.

When did SONATA 3-D IMAGING ACCESSORY, MODEL 3DS receive FDA 510(k) clearance?

SONATA 3-D IMAGING ACCESSORY, MODEL 3DS received FDA 510(k) clearance on 2004-12-23, under 510(k) number K042620.

Who is the listed applicant for SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

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

What is the FDA product code for SONATA 3-D IMAGING ACCESSORY, MODEL 3DS?

The FDA product code for SONATA 3-D IMAGING ACCESSORY, MODEL 3DS is IYO.

Related Clinical Trials

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Other records listing Tetrad Corp. 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.

K014182TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERSK013849TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERSK002193TETRAD TC-C3-ACP

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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