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FDA 510(k)

MEDICAL IMAGE DIGITIZER, MODEL 2908

K-Number: K033637 · 2003-12-17

ApplicantArray Corp.
Decision Date2003-12-17
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDICAL IMAGE DIGITIZER, MODEL 2908 is the device name listed in this FDA 510(k) record. The listed applicant is Array Corp.. It received FDA 510(k) clearance on 2003-12-17 under 510(k) number K033637. 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 MEDICAL IMAGE DIGITIZER, MODEL 2908?

MEDICAL IMAGE DIGITIZER, MODEL 2908 is a medical device that received FDA 510(k) clearance on 2003-12-17. The listed applicant is Array Corp.. The 510(k) number is K033637.

When did MEDICAL IMAGE DIGITIZER, MODEL 2908 receive FDA 510(k) clearance?

MEDICAL IMAGE DIGITIZER, MODEL 2908 received FDA 510(k) clearance on 2003-12-17, under 510(k) number K033637.

Who is the listed applicant for MEDICAL IMAGE DIGITIZER, MODEL 2908?

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

What is the FDA product code for MEDICAL IMAGE DIGITIZER, MODEL 2908?

The FDA product code for MEDICAL IMAGE DIGITIZER, MODEL 2908 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 Array 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.

K063424FILM DIGITZER, MODEL 2908 MAMMO PROK982785FILM DIGITIZER MODEL 2905

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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