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FDA 510(k)

EXPRESSSUITE

K-Number: K011049 · 2001-10-01

ApplicantVidar Systems Corp.
Decision Date2001-10-01
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXPRESSSUITE is the device name listed in this FDA 510(k) record. The listed applicant is Vidar Systems Corp.. It received FDA 510(k) clearance on 2001-10-01 under 510(k) number K011049. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPRESSSUITE?

EXPRESSSUITE is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Vidar Systems Corp.. The 510(k) number is K011049.

When did EXPRESSSUITE receive FDA 510(k) clearance?

EXPRESSSUITE received FDA 510(k) clearance on 2001-10-01, under 510(k) number K011049.

Who is the listed applicant for EXPRESSSUITE?

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

What is the FDA product code for EXPRESSSUITE?

The FDA product code for EXPRESSSUITE is LMA.

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 Vidar Systems 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.

K130636TELERADPRO EDGE; TELERADPRO EDGE HD-CCDK130406DIAGNOSTICPRO EDGEK102476TELERADPROK093809VIDAR DENTAL FILM DIGITIZERK071193VIDAR VISION 3000 AND 4000 X-RAY SYSTEMSK070563VIDAR VISION 2000

View all 13 devices →

Related Devices (Code: LMA)

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.

K132183DICOM VIDEOBar Code Computer, Ltd.K130636TELERADPRO EDGE; TELERADPRO EDGE HD-CCDVidar Systems Corp.K130406DIAGNOSTICPRO EDGEVidar Systems Corp.K102476TELERADPROVidar Systems Corp.K093809VIDAR DENTAL FILM DIGITIZERVidar Systems Corp.K091288MEDI-6000 MEDICAL IMAGE DIGITIZERMicrotek International, 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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