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 RADIOGRAPHY SYSTEM RADSPEED SAFIRE

K-Number: K050925 · 2005-06-01

ApplicantShimadzu Corp.
Decision Date2005-06-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 2005-06-01 under 510(k) number K050925. 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 DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE?

DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is Shimadzu Corp.. The 510(k) number is K050925.

When did DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE received FDA 510(k) clearance on 2005-06-01, under 510(k) number K050925.

Who is the listed applicant for DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE?

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

What is the FDA product code for DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE?

The FDA product code for DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE 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

Other records listing Shimadzu 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.

K101039SHIMADZU COLLIMATOR R-300K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400F

View all 47 devices →

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.

↑