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FDA 510(k)

COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM

K-Number: K912410 · 1991-08-13

ApplicantReality Imaging Corp.
Decision Date1991-08-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Reality Imaging Corp.. It received FDA 510(k) clearance on 1991-08-13 under 510(k) number K912410. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM?

COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-13. The listed applicant is Reality Imaging Corp.. The 510(k) number is K912410.

When did COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM receive FDA 510(k) clearance?

COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM received FDA 510(k) clearance on 1991-08-13, under 510(k) number K912410.

Who is the listed applicant for COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM?

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

What is the FDA product code for COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM?

The FDA product code for COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM is LNH.

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 Reality Imaging Corp. 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.

K883476VOXEL FLINGER(TM) 3-D IMAGING SYSTEM

Related Devices (Code: LNH)

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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