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FDA 510(k)

RADIOSCOPE OR MAMMOSCOPE

K-Number: K894412 · 1989-12-22

ApplicantVision Ten, Inc.
Decision Date1989-12-22
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOSCOPE OR MAMMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Vision Ten, Inc.. It received FDA 510(k) clearance on 1989-12-22 under 510(k) number K894412. 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 RADIOSCOPE OR MAMMOSCOPE?

RADIOSCOPE OR MAMMOSCOPE is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Vision Ten, Inc.. The 510(k) number is K894412.

When did RADIOSCOPE OR MAMMOSCOPE receive FDA 510(k) clearance?

RADIOSCOPE OR MAMMOSCOPE received FDA 510(k) clearance on 1989-12-22, under 510(k) number K894412.

Who is the listed applicant for RADIOSCOPE OR MAMMOSCOPE?

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

What is the FDA product code for RADIOSCOPE OR MAMMOSCOPE?

The FDA product code for RADIOSCOPE OR MAMMOSCOPE is LMA.

Related Clinical Trials

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Other records listing Vision Ten, 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.

K925664SERIES V-SCAN RADIOGRAPHIC FILM SCANNER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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