FDA 510(k)

Intelli-C

K-Number: K173631 · 2018-07-11

Decision Date2018-07-11

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Intelli-C 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 2018-07-11 under 510(k) number K173631. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intelli-C?

Intelli-C is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Nrt X-Ray A/S. The 510(k) number is K173631.

When did Intelli-C receive FDA 510(k) clearance?

Intelli-C received FDA 510(k) clearance on 2018-07-11, under 510(k) number K173631.

Who is the listed applicant for Intelli-C?

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 Intelli-C?

The FDA product code for Intelli-C is OWB.

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.

K242948Adora DRFi (04550010)

Related Devices (Code: OWB)

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, 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.