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
10841439114015	K180021	000
00841439114285	K180021	000
00841439114278	K180021	000
00841439114384	K180021	000
00841439114377	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
00841439114551	K180021	000
00841439114544	K180021	000
00841439114292	K180021	000
00841439114308	K180021	000
10841439114008	K180021	000
10841439113995	K180021	000
10841439113988	K180021	000
10841439113971	K180021	000
10841439113964	K180021	000
00841439113950	K180021	000
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00841439114223	K180021	000
00841439114216	K180021	000
00841439114209	K180021	000
00841439114193	K180021	000
00841439114186	K180021	000
00841439114230	K180021	000
00841439114537	K180021	000
00841439114513	K180021	000
10841439114787	K180021	000
10841439114770	K180021	000
10841439114749	K180021	000
10841439114732	K180021	000
00841439115138	K180021	000
00841439115121	K180021	000
00841439115008	K180021	000
00841439114995	K180021	000
00841439114728	K180021	000
00841439114711	K180021	000
00841439114704	K180021	000
00841439114698	K180021	000
00841439114681	K180021	000
00841439114674	K180021	000
00841439115015	K180021	000
00841439115022	K180021	000
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00841439114759	K180021	000
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00841439114650	K180021	000
00841439111536	K180021	000
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00841439113141	K180021	000
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20841439113107	K180021	000
00841439113066	K180021	000
10841439113056	K180021	000
10841439113032	K180021	000
00841439112991	K180021	000
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10841439114176	K180021	000
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10841439113520	K180021	000
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10841439113506	K180021	000
10841439113490	K180021	000
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10841439113193	K180021	000
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00841439113639	K180021	000
00841439113394	K180021	000
00841439113387	K180021	000
10841439114022	K180021	000