Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM

K-Number: K992470 · 1999-08-23

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1999-08-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1999-08-23 under 510(k) number K992470. 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 ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM?

ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-23. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K992470.

When did ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM received FDA 510(k) clearance on 1999-08-23, under 510(k) number K992470.

Who is the listed applicant for ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM?

The FDA 510(k) record lists Advanced Technology Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM?

The FDA product code for ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM 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 Advanced Technology Laboratories, 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.

K021966Q LAB SOFTWAREK011224HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITYK002144MEDLINK DIAGNOSTIC OFFLINE WORKSTATIONK991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMK961459LEVEL 10 HDIK935009PEGASUS

View all 61 devices →

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.

↑