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)

SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T

K-Number: K130883 · 2013-04-18

ApplicantSedecal., Sa.
Decision Date2013-04-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2013-04-18 under 510(k) number K130883. 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 SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T?

SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T is a medical device that received FDA 510(k) clearance on 2013-04-18. The listed applicant is Sedecal., Sa.. The 510(k) number is K130883.

When did SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T receive FDA 510(k) clearance?

SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T received FDA 510(k) clearance on 2013-04-18, under 510(k) number K130883.

Who is the listed applicant for SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T?

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

What is the FDA product code for SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T?

The FDA product code for SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T 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 Sedecal., Sa. 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.

K232185SM-IVK222951SM-VK221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.K212291PHOENIXK203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsK202293Radiographic System Challenge X

View all 24 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.

↑