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

FDA 510(k)

DIGITAL DIAGNOSTIC X-RAY SYSTEM

K-Number: K102408 · 2010-12-27

ApplicantDRGEM Corporation
Decision Date2010-12-27
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL DIAGNOSTIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2010-12-27 under 510(k) number K102408. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL DIAGNOSTIC X-RAY SYSTEM?

DIGITAL DIAGNOSTIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is DRGEM Corporation. The 510(k) number is K102408.

When did DIGITAL DIAGNOSTIC X-RAY SYSTEM receive FDA 510(k) clearance?

DIGITAL DIAGNOSTIC X-RAY SYSTEM received FDA 510(k) clearance on 2010-12-27, under 510(k) number K102408.

Who is the listed applicant for DIGITAL DIAGNOSTIC X-RAY SYSTEM?

The FDA 510(k) record lists DRGEM Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL DIAGNOSTIC X-RAY SYSTEM?

The FDA product code for DIGITAL DIAGNOSTIC X-RAY SYSTEM is KPR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing DRGEM Corporation 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.

K260085RAYMO Mobile X-ray System (Model: RAYMO)K251443PROMOK242019GXR-Series Diagnostic X-Ray SystemK242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)K202572GXR-Series Diagnostic X-Ray System

View all 14 devices →

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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.

↑