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FDA 510(k)

Insight Enhanced DRF Digital Imaging System

K-Number: K200396 · 2020-03-06

ApplicantImaging Engineering, LLC
Decision Date2020-03-06
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Insight Enhanced DRF Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Engineering, LLC. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K200396. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insight Enhanced DRF Digital Imaging System?

Insight Enhanced DRF Digital Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Imaging Engineering, LLC. The 510(k) number is K200396.

When did Insight Enhanced DRF Digital Imaging System receive FDA 510(k) clearance?

Insight Enhanced DRF Digital Imaging System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K200396.

Who is the listed applicant for Insight Enhanced DRF Digital Imaging System?

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

What is the FDA product code for Insight Enhanced DRF Digital Imaging System?

The FDA product code for Insight Enhanced DRF Digital Imaging System is JAA.

Other records listing Imaging Engineering, LLC 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.

K251650Insight Enhanced™ DRF (EN-1002-01)K210469Insight Agile DRFK191310Insight Essentials DRF Digital Imaging System

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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