Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VOXEL FLINGER(TM) 3-D IMAGING SYSTEM

K-Number: K883476 · 1988-11-23

Decision Date1988-11-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOXEL FLINGER(TM) 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 1988-11-23 under 510(k) number K883476. 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 VOXEL FLINGER(TM) 3-D IMAGING SYSTEM?

VOXEL FLINGER(TM) 3-D IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1988-11-23. The listed applicant is Reality Imaging Corp.. The 510(k) number is K883476.

When did VOXEL FLINGER(TM) 3-D IMAGING SYSTEM receive FDA 510(k) clearance?

VOXEL FLINGER(TM) 3-D IMAGING SYSTEM received FDA 510(k) clearance on 1988-11-23, under 510(k) number K883476.

Who is the listed applicant for VOXEL FLINGER(TM) 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 VOXEL FLINGER(TM) 3-D IMAGING SYSTEM?

The FDA product code for VOXEL FLINGER(TM) 3-D IMAGING SYSTEM is LLZ.

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.

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.

Related Devices (Code: LLZ)

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.

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.

↑