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FDA 510(k)

ID400 SERIES ARMBOARDS

K-Number: K950631 · 1995-03-24

ApplicantImage Diagnostics, Inc.
Decision Date1995-03-24
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ID400 SERIES ARMBOARDS is the device name listed in this FDA 510(k) record. The listed applicant is Image Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K950631. 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 ID400 SERIES ARMBOARDS?

ID400 SERIES ARMBOARDS is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Image Diagnostics, Inc.. The 510(k) number is K950631.

When did ID400 SERIES ARMBOARDS receive FDA 510(k) clearance?

ID400 SERIES ARMBOARDS received FDA 510(k) clearance on 1995-03-24, under 510(k) number K950631.

Who is the listed applicant for ID400 SERIES ARMBOARDS?

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

What is the FDA product code for ID400 SERIES ARMBOARDS?

The FDA product code for ID400 SERIES ARMBOARDS is JAA.

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Other records listing Image Diagnostics, Inc. 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.

K944772MULTIPLE ED1600 SERIES RADIATION SHIELDSK942190ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE

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

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