PRE-LOADED VISICOIL

Accelerator, Linear, Medical

RADIOMED CORPORATION

The following data is part of a premarket notification filed by Radiomed Corporation with the FDA for Pre-loaded Visicoil.

Pre-market Notification Details

• Device ID: K070305
• 510k Number: K070305
• Device Name: PRE-LOADED VISICOIL
• Classification: Accelerator, Linear, Medical
• Applicant: RADIOMED CORPORATION ONE INDUSTRIAL WAY Tyngsboro, MA 01879 -1400
• Contact: Gordon Roberts
• Correspondent: Gordon Roberts; RADIOMED CORPORATION ONE INDUSTRIAL WAY Tyngsboro, MA 01879 -1400
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-01
• Decision Date: 2007-03-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B887VC075010PL0	K070305	000
B887VC035010PL0	K070305	000
B887VC035005PL0	K070305	000
B887SN050020PL150	K070305	000
B887SN050020PL080	K070305	000
B887SN050010PL150	K070305	000
B887SN050010PL080	K070305	000
B887SN050005PL150	K070305	000
B887SN050005PL080	K070305	000
B887SN035020PL150	K070305	000
B887SN035020PL080	K070305	000
B887SN035010PL150	K070305	000
B887VC035020PL0	K070305	000
B887VC035030PL0	K070305	000
B887VC035040PL0	K070305	000
B887VC075005PL300	K070305	000
B887VC075005PL120	K070305	000
B887VC075005PL0	K070305	000
B887VC050020PLSL0	K070305	000
B887VC050020PL0	K070305	000
B887VC050010PLSL0	K070305	000
B887VC050010PL300	K070305	000
B887VC050010PL0	K070305	000
B887VC050005PLSL0	K070305	000
B887VC050005PL300	K070305	000
B887VC050005PL0	K070305	000
B887SN035010PL080	K070305	000
B887SN035005PL150	K070305	000
B887GF15230	K070305	000
B887GF15210	K070305	000
B887GF13340	K070305	000
B887GF13330	K070305	000
B887GF13310	K070305	000
B887GF13240	K070305	000
B887LITPTN3MR0	K070305	000
B887KITPTN3MR0	K070305	000
B887SN050010PL200	K070305	000
B887SN050005PL200	K070305	000
B887SN035010PL200	K070305	000
B887GF15240	K070305	000
B887GF15310	K070305	000
B887GF15330	K070305	000
B887SN035005PL080	K070305	000
B887KITSPN8PL0	K070305	000
B887GF1321	K070305	000
B887GF13210	K070305	000
B887GF1001	K070305	000
B887GF10010	K070305	000
B887GF10040	K070305	000
B887GF10030	K070305	000
B887GF13230	K070305	000
B887GF18230	K070305	000
B887GF15340	K070305	000
B887SN035005PL200	K070305	000
EIBAKITSPN8PL0	K070305	000
EIBAVC075005PL120	K070305	000
EIBAVC075005PL0	K070305	000
EIBAVC050020PLSL0	K070305	000
EIBAVC050020PL0	K070305	000
EIBAVC050010PLSL0	K070305	000
EIBAVC050010PL300	K070305	000
EIBAVC050010PL0	K070305	000
EIBAVC050005PLSL0	K070305	000
EIBAVC050005PL300	K070305	000
EIBAVC050005PL0	K070305	000
EIBAVC035040PL0	K070305	000
EIBAVC075005PL300	K070305	000
EIBAVC075010PL0	K070305	000
EIBAVC075010PL120	K070305	000
EIBAVC110030PL0	K070305	000
EIBAVC110020PL300	K070305	000
EIBAVC110020PL0	K070305	000
EIBAVC110010PL300	K070305	000
EIBAVC110010PL0	K070305	000
EIBAVC110005PL0	K070305	000
EIBAVC075030PL0	K070305	000
EIBAVC075020PL300	K070305	000
EIBAVC075020PL120	K070305	000
EIBAVC075020PL0	K070305	000
EIBAVC075010PL300	K070305	000
EIBAVC035030PL0	K070305	000
EIBAVC035020PL0	K070305	000
B887VC110030PL0	K070305	000
B887VC110020PL300	K070305	000
B887VC110020PL0	K070305	000
B887VC110010PL300	K070305	000
B887VC110010PL0	K070305	000
B887VC110005PL0	K070305	000
B887VC075030PL0	K070305	000
B887VC075020PL300	K070305	000
B887VC075020PL120	K070305	000
B887VC075020PL0	K070305	000
B887VC075010PL300	K070305	000
EIBASN035005PL080	K070305	000
EIBASN035005PL150	K070305	000
EIBASN035010PL080	K070305	000
EIBAVC035010PL0	K070305	000
EIBAVC035005PL0	K070305	000
EIBASN050020PL150	K070305	000
EIBASN050020PL080	K070305	000
EIBASN050010PL150	K070305	000
EIBASN050010PL080	K070305	000
EIBASN050005PL150	K070305	000
EIBASN050005PL080	K070305	000
EIBASN035020PL150	K070305	000
EIBASN035020PL080	K070305	000
EIBASN035010PL150	K070305	000
B887VC075010PL120	K070305	000