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)

VTR-12

K-Number: K882176 · 1988-08-11

ApplicantEigen
Decision Date1988-08-11
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VTR-12 is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 1988-08-11 under 510(k) number K882176. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VTR-12?

VTR-12 is a medical device that received FDA 510(k) clearance on 1988-08-11. The listed applicant is Eigen. The 510(k) number is K882176.

When did VTR-12 receive FDA 510(k) clearance?

VTR-12 received FDA 510(k) clearance on 1988-08-11, under 510(k) number K882176.

Who is the listed applicant for VTR-12?

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

What is the FDA product code for VTR-12?

The FDA product code for VTR-12 is JAA.

Other records listing Eigen 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.

K222222Artemis, Artemis TPO, Artemis MXK173744ProFuse CADK162474ArtemisK063846EIGEN DSA 2000K933115DIGITAL DISK RECORDERK924164DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT

View all 16 devices →

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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.

↑