Proton Positioing And Immobilization Devices

Accelerator, Linear, Medical

MEDTEC, Inc. D/b/a "CIVCO Medical Solutions" And "CIVCO Radi

The following data is part of a premarket notification filed by Medtec, Inc. D/b/a "civco Medical Solutions" And "civco Radi with the FDA for Proton Positioing And Immobilization Devices.

Pre-market Notification Details

• Device ID: K180021
• 510k Number: K180021
• Device Name: Proton Positioing And Immobilization Devices
• Classification: Accelerator, Linear, Medical
• Applicant: MEDTEC, Inc. D/b/a "CIVCO Medical Solutions" And "CIVCO Radi 140 L 8th Street SE Orange City, IA 51041
• Contact: Alena Newgren
• Correspondent: Alena Newgren; MEDTEC, Inc. D/b/a "CIVCO Medical Solutions" And "CIVCO Radi 140 L 8th Street SE Orange City, IA 51041
• Product Code: IYE
• Subsequent Product Code: IXQ
• Subsequent Product Code: LNH
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-03
• Decision Date: 2018-06-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841439113875	K180021	000
00841439113943	K180021	000
00841439113936	K180021	000
00841439114223	K180021	000
00841439114216	K180021	000
00841439114209	K180021	000
00841439114193	K180021	000
00841439114186	K180021	000
00841439114230	K180021	000
00841439114308	K180021	000
00841439114292	K180021	000
00841439114285	K180021	000
00841439113950	K180021	000
10841439113964	K180021	000
10841439113971	K180021	000
00841439113783	K180021	000
00841439113356	K180021	000
00841439113073	K180021	000
10841439114176	K180021	000
00841439114049	K180021	000
10841439114039	K180021	000
10841439114022	K180021	000
10841439114015	K180021	000
10841439114008	K180021	000
10841439113995	K180021	000
10841439113988	K180021	000
00841439114278	K180021	000
00841439114384	K180021	000
00841439114377	K180021	000
10841439113681	K180021	000
10841439113674	K180021	000
10841439113667	K180021	000
10841439113650	K180021	000
00841439114599	K180021	000
00841439114643	K180021	000
00841439114636	K180021	000
00841439114629	K180021	000
00841439114612	K180021	000
00841439114759	K180021	000
00841439114766	K180021	000
10841439113698	K180021	000
10841439113704	K180021	000
00841439114513	K180021	000
00841439114360	K180021	000
00841439114353	K180021	000
00841439114421	K180021	000
00841439114414	K180021	000
00841439114407	K180021	000
00841439114391	K180021	000
00841439114346	K180021	000
00841439113578	K180021	000
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00841439114537	K180021	000
00841439115039	K180021	000
00841439113882	K180021	000
00841439111536	K180021	000
00841439106457	K180021	000
00841439106440	K180021	000
00841439112465	K180021	000
00841439113141	K180021	000
00841439113134	K180021	000
20841439113107	K180021	000
00841439113066	K180021	000
10841439113056	K180021	000
10841439113032	K180021	000
00841439112991	K180021	000
00841439112984	K180021	000
00841439106464	K180021	000
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00841439110768	K180021	000
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00841439106402	K180021	000
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00841439110287	K180021	000
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00841439107102	K180021	000
00841439106495	K180021	000
00841439112700	K180021	000
10841439113261	K180021	000
10841439113254	K180021	000
10841439113179	K180021	000
00841439113639	K180021	000
00841439113394	K180021	000
00841439113387	K180021	000
00841439113868	K180021	000
00841439113851	K180021	000
00841439113844	K180021	000
00841439113837	K180021	000
00841439113820	K180021	000
00841439113813	K180021	000
00841439113806	K180021	000
10841439113186	K180021	000
10841439113193	K180021	000
10841439113469	K180021	000
10841439113209	K180021	000
00841439113325	K180021	000
00841439113622	K180021	000
00841439113608	K180021	000
10841439113582	K180021	000
10841439113520	K180021	000
10841439113513	K180021	000
10841439113506	K180021	000
10841439113490	K180021	000
10841439113483	K180021	000
10841439113476	K180021	000
00841439113646	K180021	000