Atlas FDA

1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS

FDA 510(k) clearance K093689 · decided 2010-08-31

Clearance details

K-number
K093689
Device name
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
Applicant
Mr Medical Solutions, LLC
Decision
Substantially Equivalent
Date received
2009-11-30
Decision date
2010-08-31
Days to decision
274 days
Clearance type
Traditional
Product code
MOS
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Pittsburg, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.