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FDA 510(k)

Adora DRFi (04550010)

K-Number: K242948 · 2024-12-23

ApplicantNrt X-Ray A/S
Decision Date2024-12-23
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Adora DRFi (04550010) is the device name listed in this FDA 510(k) record. The listed applicant is Nrt X-Ray A/S. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242948. 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 Adora DRFi (04550010)?

Adora DRFi (04550010) is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Nrt X-Ray A/S. The 510(k) number is K242948.

When did Adora DRFi (04550010) receive FDA 510(k) clearance?

Adora DRFi (04550010) received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242948.

Who is the listed applicant for Adora DRFi (04550010)?

The FDA 510(k) record lists Nrt X-Ray A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adora DRFi (04550010)?

The FDA product code for Adora DRFi (04550010) is JAA.

Other records listing Nrt X-Ray A/S 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.

K173631Intelli-C

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, LLCK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbHK232910CombiDiagnost R90Philips 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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