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FDA 510(k)

TELERADPRO EDGE; TELERADPRO EDGE HD-CCD

K-Number: K130636 · 2013-06-07

ApplicantVidar Systems Corp.
Decision Date2013-06-07
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TELERADPRO EDGE; TELERADPRO EDGE HD-CCD 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 2013-06-07 under 510(k) number K130636. 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 TELERADPRO EDGE; TELERADPRO EDGE HD-CCD?

TELERADPRO EDGE; TELERADPRO EDGE HD-CCD is a medical device that received FDA 510(k) clearance on 2013-06-07. The listed applicant is Vidar Systems Corp.. The 510(k) number is K130636.

When did TELERADPRO EDGE; TELERADPRO EDGE HD-CCD receive FDA 510(k) clearance?

TELERADPRO EDGE; TELERADPRO EDGE HD-CCD received FDA 510(k) clearance on 2013-06-07, under 510(k) number K130636.

Who is the listed applicant for TELERADPRO EDGE; TELERADPRO EDGE HD-CCD?

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 TELERADPRO EDGE; TELERADPRO EDGE HD-CCD?

The FDA product code for TELERADPRO EDGE; TELERADPRO EDGE HD-CCD is LMA.

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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.

K130406DIAGNOSTICPRO EDGEK102476TELERADPROK093809VIDAR DENTAL FILM DIGITIZERK071193VIDAR VISION 3000 AND 4000 X-RAY SYSTEMSK070563VIDAR VISION 2000K024171VIDAR BONE TRACK SYSTEM SOFTWARE

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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.K130406DIAGNOSTICPRO EDGEVidar Systems Corp.K102476TELERADPROVidar Systems Corp.K093809VIDAR DENTAL FILM DIGITIZERVidar Systems Corp.K091288MEDI-6000 MEDICAL IMAGE DIGITIZERMicrotek International, Inc.K063424FILM DIGITZER, MODEL 2908 MAMMO PROArray Corp.

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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