Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DR 100s

K-Number: K191884 · 2019-08-09

ApplicantAgfa N.V.
Decision Date2019-08-09
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR 100s is a medical device manufactured by Agfa N.V.. It received FDA 510(k) clearance on 2019-08-09 under approval number K191884. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR 100s?

DR 100s is a medical device that received FDA 510(k) clearance on 2019-08-09. It is manufactured by Agfa N.V.. The 510(k) number is K191884.

When was DR 100s approved by the FDA?

DR 100s received FDA 510(k) clearance on 2019-08-09, under approval number K191884.

What company makes DR 100s?

DR 100s is manufactured by Agfa N.V..

What is the FDA product code for DR 100s?

The FDA product code for DR 100s is IZL.

Other Devices by Agfa N.V.

K183275DR 800 with Tomosynthesis K193262DR 600 with Tomosynthesis K213469VALORY K212145DR 800 with DSA, DR 800 K211790DX-D Imaging Package with XD Detectors

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, 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.

↑