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FDA 510(k)

4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ

K-Number: K101166 · 2010-10-07

ApplicantGE Healthcare
Decision Date2010-10-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2010-10-07 under 510(k) number K101166. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ?

4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is GE Healthcare. The 510(k) number is K101166.

When did 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ receive FDA 510(k) clearance?

4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ received FDA 510(k) clearance on 2010-10-07, under 510(k) number K101166.

Who is the listed applicant for 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ?

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

What is the FDA product code for 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ?

The FDA product code for 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ is LLZ.

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Other records listing GE Healthcare 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

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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