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FDA 510(k)

3DHJD CAMERA SYSTEM MODEL

K-Number: K101810 · 2010-08-30

ApplicantVision Systems Group, A Division of Viking Systems
Decision Date2010-08-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3DHJD CAMERA SYSTEM MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Vision Systems Group, A Division of Viking Systems. It received FDA 510(k) clearance on 2010-08-30 under 510(k) number K101810. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DHJD CAMERA SYSTEM MODEL?

3DHJD CAMERA SYSTEM MODEL is a medical device that received FDA 510(k) clearance on 2010-08-30. The listed applicant is Vision Systems Group, A Division of Viking Systems. The 510(k) number is K101810.

When did 3DHJD CAMERA SYSTEM MODEL receive FDA 510(k) clearance?

3DHJD CAMERA SYSTEM MODEL received FDA 510(k) clearance on 2010-08-30, under 510(k) number K101810.

Who is the listed applicant for 3DHJD CAMERA SYSTEM MODEL?

The FDA 510(k) record lists Vision Systems Group, A Division of Viking Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DHJD CAMERA SYSTEM MODEL?

The FDA product code for 3DHJD CAMERA SYSTEM MODEL is GCJ.

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.

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Other records listing Vision Systems Group, A Division of Viking Systems 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.

K081585ENDOSCOPY VIDEO CAMERA SYSTEM

Related Devices (Code: GCJ)

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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