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FDA 510(k)

GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955

K-Number: K051734 · 2005-11-23

ApplicantGe Healthcare Technologies
Decision Date2005-11-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Technologies. It received FDA 510(k) clearance on 2005-11-23 under 510(k) number K051734. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955?

GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is Ge Healthcare Technologies. The 510(k) number is K051734.

When did GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 receive FDA 510(k) clearance?

GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 received FDA 510(k) clearance on 2005-11-23, under 510(k) number K051734.

Who is the listed applicant for GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955?

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

What is the FDA product code for GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955?

The FDA product code for GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 is HAW.

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Other records listing Ge Healthcare Technologies 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.

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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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