Intelli-C
K-Number: K173631 · 2018-07-11
ApplicantNrt X-Ray A/S
Decision Date2018-07-11
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Intelli-C is a medical device manufactured by Nrt X-Ray A/S. It received FDA 510(k) clearance on 2018-07-11 under approval 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. It is manufactured by Nrt X-Ray A/S. The 510(k) number is K173631.
When was Intelli-C approved by the FDA?
Intelli-C received FDA 510(k) clearance on 2018-07-11, under approval number K173631.
What company makes Intelli-C?
Intelli-C is manufactured by Nrt X-Ray A/S.
What is the FDA product code for Intelli-C?
The FDA product code for Intelli-C is OWB.
Other Devices by Nrt X-Ray A/S
Related Devices (Code: OWB)
K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.
K162148Allura Xper R9Philips Medical Systems Nethrlands BV
K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation
K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.
K161976Ziehm Solo FDZiehm Imaging GmbH
K161756SyncVision SystemVolcano Corporation
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.