Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
K-Number: K201800 · 2020-12-28
ApplicantNanoray Co., Ltd.
Decision Date2020-12-28
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) is a medical device manufactured by Nanoray Co., Ltd.. It received FDA 510(k) clearance on 2020-12-28 under approval number K201800. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)?
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) is a medical device that received FDA 510(k) clearance on 2020-12-28. It is manufactured by Nanoray Co., Ltd.. The 510(k) number is K201800.
When was Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) approved by the FDA?
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) received FDA 510(k) clearance on 2020-12-28, under approval number K201800.
What company makes Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)?
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) is manufactured by Nanoray Co., Ltd..
What is the FDA product code for Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)?
The FDA product code for Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) is EHD.
Related Devices (Code: EHD)
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.