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)

PHORMAX EAGLE SCANNER SYSTEM

K-Number: K001499 · 2000-12-27

ApplicantPhormax Corp.
Decision Date2000-12-27
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHORMAX EAGLE SCANNER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Phormax Corp.. It received FDA 510(k) clearance on 2000-12-27 under 510(k) number K001499. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHORMAX EAGLE SCANNER SYSTEM?

PHORMAX EAGLE SCANNER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-27. The listed applicant is Phormax Corp.. The 510(k) number is K001499.

When did PHORMAX EAGLE SCANNER SYSTEM receive FDA 510(k) clearance?

PHORMAX EAGLE SCANNER SYSTEM received FDA 510(k) clearance on 2000-12-27, under 510(k) number K001499.

Who is the listed applicant for PHORMAX EAGLE SCANNER SYSTEM?

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

What is the FDA product code for PHORMAX EAGLE SCANNER SYSTEM?

The FDA product code for PHORMAX EAGLE SCANNER SYSTEM is MQB.

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

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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.

↑