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FDA 510(k)

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM

K-Number: K042733 · 2004-11-15

ApplicantStandard Imaging, Inc.
Decision Date2004-11-15
Product CodeLHO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Standard Imaging, Inc.. It received FDA 510(k) clearance on 2004-11-15 under 510(k) number K042733. The device is classified under product code LHO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM?

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-15. The listed applicant is Standard Imaging, Inc.. The 510(k) number is K042733.

When did STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM receive FDA 510(k) clearance?

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM received FDA 510(k) clearance on 2004-11-15, under 510(k) number K042733.

Who is the listed applicant for STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM?

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

What is the FDA product code for STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM?

The FDA product code for STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM is LHO.

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Other records listing Standard Imaging, 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.

K103193DOSEVIEW 3DK082773STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331K060532HDR 1000 PLUS WELL CHAMBER, MODEL 90008K040688STANDARD IMAGING E.IMRT CALCULATORK013548STANDARD IMAGING IVB 1000 WELL CHAMBERK002833MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER

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Related Devices (Code: LHO)

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K873956ULTIMETERRadiation Measurements, Inc.K853754MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901Victoreen, Inc.K860260MULTI PURPOSE MODEL 76-903Victoreen, Inc.K860100MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902Victoreen, Inc.K844620BDS-3 BEAM DATA SCANNERVarian Assoc., Inc.K845007RFA-7 RADIATION FIELD ANALYZERVarian Assoc., 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.

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