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FDA 510(k), K052164, MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
FDA 510(k), K052164, MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
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510(K) Number: K052164
Device Name: MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
Manufacturer: JUDITH CAMPBELL
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 08/09/2005
Decision Date: 10/04/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
Manufacturer: JUDITH CAMPBELL
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 08/09/2005
Decision Date: 10/04/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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