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)

ALPHA II

K-Number: K931725 · 1993-07-14

ApplicantDynarad Corp.
Decision Date1993-07-14
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA II is the device name listed in this FDA 510(k) record. The listed applicant is Dynarad Corp.. It received FDA 510(k) clearance on 1993-07-14 under 510(k) number K931725. 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 ALPHA II?

ALPHA II is a medical device that received FDA 510(k) clearance on 1993-07-14. The listed applicant is Dynarad Corp.. The 510(k) number is K931725.

When did ALPHA II receive FDA 510(k) clearance?

ALPHA II received FDA 510(k) clearance on 1993-07-14, under 510(k) number K931725.

Who is the listed applicant for ALPHA II?

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

What is the FDA product code for ALPHA II?

The FDA product code for ALPHA II is EHD.

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 Dynarad Corp. 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.

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330K981267FACTS MONOBLOCKK973833CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUALK932356NOVA XM2K941363PHANTOMK932353HF-110A

View all 9 devices →

Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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.

↑