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)

CR 10-X DIGITIZER

K-Number: K121948 · 2012-07-20

ApplicantAgfa Healthcare N.V.
Decision Date2012-07-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CR 10-X DIGITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2012-07-20 under 510(k) number K121948. 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 CR 10-X DIGITIZER?

CR 10-X DIGITIZER is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K121948.

When did CR 10-X DIGITIZER receive FDA 510(k) clearance?

CR 10-X DIGITIZER received FDA 510(k) clearance on 2012-07-20, under 510(k) number K121948.

Who is the listed applicant for CR 10-X DIGITIZER?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CR 10-X DIGITIZER?

The FDA product code for CR 10-X DIGITIZER 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 Agfa Healthcare N.V. 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.

K252199AGFA HealthCare Enterprise ImagingK180589DR 800 with MUSICA DynamicK172784DX-D Imaging PackageK170434Enterprise Imaging XERO Viewer 8.1K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)K161061IMPAX Volume Viewing 4.0

View all 19 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.

↑