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FDA 510(k)

JANUS I

K-Number: K952551 · 1995-12-11

Applicant3D Ultrasound, Inc.
Decision Date1995-12-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JANUS I is the device name listed in this FDA 510(k) record. The listed applicant is 3D Ultrasound, Inc.. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K952551. 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 JANUS I?

JANUS I is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is 3D Ultrasound, Inc.. The 510(k) number is K952551.

When did JANUS I receive FDA 510(k) clearance?

JANUS I received FDA 510(k) clearance on 1995-12-11, under 510(k) number K952551.

Who is the listed applicant for JANUS I?

The FDA 510(k) record lists 3D Ultrasound, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JANUS I?

The FDA product code for JANUS I is IYO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing 3D Ultrasound, Inc. 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.

K963863JANUS I

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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