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FDA 510(k)

DVT SCANNER

K-Number: K051980 · 2005-08-19

ApplicantImaging Sciences Intl., Inc.
Decision Date2005-08-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DVT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Sciences Intl., Inc.. It received FDA 510(k) clearance on 2005-08-19 under 510(k) number K051980. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DVT SCANNER?

DVT SCANNER is a medical device that received FDA 510(k) clearance on 2005-08-19. The listed applicant is Imaging Sciences Intl., Inc.. The 510(k) number is K051980.

When did DVT SCANNER receive FDA 510(k) clearance?

DVT SCANNER received FDA 510(k) clearance on 2005-08-19, under 510(k) number K051980.

Who is the listed applicant for DVT SCANNER?

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

What is the FDA product code for DVT SCANNER?

The FDA product code for DVT SCANNER is JAK.

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 Imaging Sciences Intl., 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.

K061284I-CAT SCANNERK041078SURGPLAN AND PANPLANK001248MULTI-PULSE 2000K991518PANATOMEK981466XR-910K9318152000 X-RAY - TOMOGRAPHIC

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Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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