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)

RAYMO Mobile X-ray System (Model: RAYMO)

K-Number: K260085 · 2026-05-14

ApplicantDRGEM Corporation
Decision Date2026-05-14
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAYMO Mobile X-ray System (Model: RAYMO) is a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2026-05-14 under approval number K260085. 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 RAYMO Mobile X-ray System (Model: RAYMO)?

RAYMO Mobile X-ray System (Model: RAYMO) is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by DRGEM Corporation. The 510(k) number is K260085.

When was RAYMO Mobile X-ray System (Model: RAYMO) approved by the FDA?

RAYMO Mobile X-ray System (Model: RAYMO) received FDA 510(k) clearance on 2026-05-14, under approval number K260085.

What company makes RAYMO Mobile X-ray System (Model: RAYMO)?

RAYMO Mobile X-ray System (Model: RAYMO) is manufactured by DRGEM Corporation.

What is the FDA product code for RAYMO Mobile X-ray System (Model: RAYMO)?

The FDA product code for RAYMO Mobile X-ray System (Model: RAYMO) is IZL.

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.

↑