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FDA 510(k)

B-350 CEILING MOUNTED C-POSITIONER

K-Number: K970947 · 1997-05-14

ApplicantOmega Medical Imaging, Inc.
Decision Date1997-05-14
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

B-350 CEILING MOUNTED C-POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Imaging, Inc.. It received FDA 510(k) clearance on 1997-05-14 under 510(k) number K970947. 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 B-350 CEILING MOUNTED C-POSITIONER?

B-350 CEILING MOUNTED C-POSITIONER is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Omega Medical Imaging, Inc.. The 510(k) number is K970947.

When did B-350 CEILING MOUNTED C-POSITIONER receive FDA 510(k) clearance?

B-350 CEILING MOUNTED C-POSITIONER received FDA 510(k) clearance on 1997-05-14, under 510(k) number K970947.

Who is the listed applicant for B-350 CEILING MOUNTED C-POSITIONER?

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

What is the FDA product code for B-350 CEILING MOUNTED C-POSITIONER?

The FDA product code for B-350 CEILING MOUNTED C-POSITIONER is JAA.

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Other records listing Omega Medical Imaging, 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.

K100102CS-SERIES-FPK093572R650 QDASM COLLIMATORK070834CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)K062647E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50K050092R605 FACS COLLIMETERK990055B-400 CEILING MOUNTED POSSITIONER, MODEL B-400

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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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