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FDA 510(k)

XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

K-Number: K111167 · 2011-08-18

ApplicantVelopex International, Inc.
Decision Date2011-08-18
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT is the device name listed in this FDA 510(k) record. The listed applicant is Velopex International, Inc.. It received FDA 510(k) clearance on 2011-08-18 under 510(k) number K111167. The device is classified under product code IXW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT?

XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT is a medical device that received FDA 510(k) clearance on 2011-08-18. The listed applicant is Velopex International, Inc.. The 510(k) number is K111167.

When did XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT receive FDA 510(k) clearance?

XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT received FDA 510(k) clearance on 2011-08-18, under 510(k) number K111167.

Who is the listed applicant for XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT?

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

What is the FDA product code for XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT?

The FDA product code for XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT is IXW.

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 Velopex International, Inc. 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.

K093503INTRAX FILM PROCESSORK024105VELOPEX AQUACUT FLUID ABRASION UNIT

Related Devices (Code: IXW)

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.

K093503INTRAX FILM PROCESSORVelopex International, Inc.K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAXProtec GmbH & Co. KGK024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000Daito Co., Ltd.K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.K023613AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036Alphatek Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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