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FDA 510(k)

SC-1000 WITH SUFFIXES (SCAN CONVERTER)

K-Number: K890745 · 1989-03-14

ApplicantEigen
Decision Date1989-03-14
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SC-1000 WITH SUFFIXES (SCAN CONVERTER) is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K890745. 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 SC-1000 WITH SUFFIXES (SCAN CONVERTER)?

SC-1000 WITH SUFFIXES (SCAN CONVERTER) is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Eigen. The 510(k) number is K890745.

When did SC-1000 WITH SUFFIXES (SCAN CONVERTER) receive FDA 510(k) clearance?

SC-1000 WITH SUFFIXES (SCAN CONVERTER) received FDA 510(k) clearance on 1989-03-14, under 510(k) number K890745.

Who is the listed applicant for SC-1000 WITH SUFFIXES (SCAN CONVERTER)?

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 SC-1000 WITH SUFFIXES (SCAN CONVERTER)?

The FDA product code for SC-1000 WITH SUFFIXES (SCAN CONVERTER) is JAA.

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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

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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.

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