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FDA 510(k)

MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205

K-Number: K993598 · 2000-01-20

ApplicantVidar Systems Corp.
Decision Date2000-01-20
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 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 2000-01-20 under 510(k) number K993598. 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 MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205?

MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 is a medical device that received FDA 510(k) clearance on 2000-01-20. The listed applicant is Vidar Systems Corp.. The 510(k) number is K993598.

When did MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 receive FDA 510(k) clearance?

MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 received FDA 510(k) clearance on 2000-01-20, under 510(k) number K993598.

Who is the listed applicant for MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205?

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 MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205?

The FDA product code for MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 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.

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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.

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

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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.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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