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)

PCCR DIGITAL IMAGING DEVICE

K-Number: K003256 · 2000-11-08

ApplicantOrex Computed Radiography, Ltd.
Decision Date2000-11-08
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PCCR DIGITAL IMAGING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Orex Computed Radiography, Ltd.. It received FDA 510(k) clearance on 2000-11-08 under 510(k) number K003256. 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 PCCR DIGITAL IMAGING DEVICE?

PCCR DIGITAL IMAGING DEVICE is a medical device that received FDA 510(k) clearance on 2000-11-08. The listed applicant is Orex Computed Radiography, Ltd.. The 510(k) number is K003256.

When did PCCR DIGITAL IMAGING DEVICE receive FDA 510(k) clearance?

PCCR DIGITAL IMAGING DEVICE received FDA 510(k) clearance on 2000-11-08, under 510(k) number K003256.

Who is the listed applicant for PCCR DIGITAL IMAGING DEVICE?

The FDA 510(k) record lists Orex Computed Radiography, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PCCR DIGITAL IMAGING DEVICE?

The FDA product code for PCCR DIGITAL IMAGING DEVICE 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 Orex Computed Radiography, Ltd. 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.

K073670KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260K032654PORT CASSETTE

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.

↑