Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)

Accelerator, Linear, Medical

RadioMed Corporation

The following data is part of a premarket notification filed by Radiomed Corporation with the FDA for Visicoil Mr Marker (user Loaded), Visicoil Mr Marker (pre-loaded).

Pre-market Notification Details

• Device ID: K161724
• 510k Number: K161724
• Device Name: Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
• Classification: Accelerator, Linear, Medical
• Applicant: RadioMed Corporation 3150 Stage Post Drive Suite 110 Bartlett, TN 38133
• Contact: Leah Easley
• Correspondent: Leah Easley; RadioMed Corporation 3150 Stage Post Drive Suite 110 Bartlett, TN 38133
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-22
• Decision Date: 2017-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B887SNMR03500522080	K161724	000
B887MRFP0350050	K161724	000
B887MR075010PL0	K161724	000
B887MR075005PL0	K161724	000
B887MR050010PL0	K161724	000
B887MR050005PL0	K161724	000
B887MR005005PL0	K161724	000
SHZ03501022	K161724	000
SHZ03500522	K161724	000
B887SHZ035010220	K161724	000
B887MRFP0350100	K161724	000
B887MRFP0350200	K161724	000
B887MRFP1000200	K161724	000
B887MRFP1000100	K161724	000
B887MRFP1000050	K161724	000
B887MRFP0750200	K161724	000
B887MRFP0750100	K161724	000
B887MRFP0750050	K161724	000
B887MRFP0500200	K161724	000
B887MRFP0500100	K161724	000
B887MRFP0500050	K161724	000
B887SHZ035005220	K161724	000
B887GF1501	K161724	000
B887SNMR05002021080	K161724	000
B887SNMR05001021080	K161724	000
B887MR075020PL0	K161724	000
B887SNMR05002021200	K161724	000
B887SNMR05002021150	K161724	000
B887SHZ035020220	K161724	000
B887MR05001019200	K161724	000
B887MR05000519200	K161724	000
B887MR050020PL0	K161724	000
B887SNMR05000521200	K161724	000
B887MR100005PL0	K161724	000
B887GF15010	K161724	000
B887GF03033	K161724	000
B887GF03020	K161724	000
B887GF15030	K161724	000
B887GF03030	K161724	000
SNMR0500050	K161724	000
SHZ03502022	K161724	000
B887MR100020PL0	K161724	000
B887MR100010PL0	K161724	000
SNMR05000521200	K161724	000
B887SNMR03500522150	K161724	000
EIBASNMR05001021200	K161724	000
EIBASNMR03500522200	K161724	000
EIBASNMR03500522150	K161724	000
EIBASNMR03500522080	K161724	000
EIBAMRFP1000200	K161724	000
EIBAMRFP1000100	K161724	000
EIBAMRFP1000050	K161724	000
EIBAMRFP0750200	K161724	000
EIBAMRFP0750100	K161724	000
EIBAMRFP0750050	K161724	000
EIBASNMR03501022080	K161724	000
EIBASNMR03501022150	K161724	000
EIBASNMR05001021150	K161724	000
EIBASNMR05000521200	K161724	000
EIBASNMR05000521150	K161724	000
EIBASNMR05000521080	K161724	000
EIBASNMR03503022200	K161724	000
EIBASNMR03502022200	K161724	000
EIBASNMR03502022150	K161724	000
EIBASNMR03502022080	K161724	000
EIBASNMR03501022200	K161724	000
EIBAMRFP0500200	K161724	000
EIBAMRFP0500100	K161724	000
B887SNMR05000521150	K161724	000
B887SNMR05000521080	K161724	000
B887SNMR03503022200	K161724	000
B887SNMR03502022200	K161724	000
B887SNMR03502022150	K161724	000
B887SNMR03502022080	K161724	000
B887SNMR03501022200	K161724	000
B887SNMR03501022150	K161724	000
B887SNMR03501022080	K161724	000
B887SNMR05001021150	K161724	000
B887SNMR05001021200	K161724	000
EIBAMRFP0500050	K161724	000
EIBAMRFP0350200	K161724	000
EIBAMRFP0350100	K161724	000
EIBAMRFP0350050	K161724	000
EIBAMR075010PL0	K161724	000
EIBAMR075005PL0	K161724	000
EIBAMR050010PL0	K161724	000
EIBAMR050005PL0	K161724	000
EIBAMR005005PL0	K161724	000
B887SNMR03500522200	K161724	000