FDA 510(k)

AIDA WITH DICOM AND HL7 INTERFACE

K-Number: K043324 · 2005-04-04

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date2005-04-04

Product CodeFET

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AIDA WITH DICOM AND HL7 INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2005-04-04 under 510(k) number K043324. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIDA WITH DICOM AND HL7 INTERFACE?

AIDA WITH DICOM AND HL7 INTERFACE is a medical device that received FDA 510(k) clearance on 2005-04-04. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K043324.

When did AIDA WITH DICOM AND HL7 INTERFACE receive FDA 510(k) clearance?

AIDA WITH DICOM AND HL7 INTERFACE received FDA 510(k) clearance on 2005-04-04, under 510(k) number K043324.

Who is the listed applicant for AIDA WITH DICOM AND HL7 INTERFACE?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIDA WITH DICOM AND HL7 INTERFACE?

The FDA product code for AIDA WITH DICOM AND HL7 INTERFACE is FET.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes

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Related Devices (Code: FET)

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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.