The AIO Solution

Accelerator, Linear, Medical

Orfit Industries NV

The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for The Aio Solution.

Pre-market Notification Details

• Device ID: K191158
• 510k Number: K191158
• Device Name: The AIO Solution
• Classification: Accelerator, Linear, Medical
• Applicant: Orfit Industries NV 9A, Vosveld Wijnegem, BE 2110
• Contact: Eddy Marivoet
• Correspondent: Ray Kelly; Arazy Group Consultants Inc. 68 Southwood Terrace Southbury, CT 06488
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-01
• Decision Date: 2019-08-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05420028700105	K191158	000
05420028712054	K191158	000
05420028712061	K191158	000
05420028712078	K191158	000
05420028712085	K191158	000
05420028712436	K191158	000
05420028712740	K191158	000
05420028712757	K191158	000
05420028712801	K191158	000
05420028712887	K191158	000
05420028712955	K191158	000
05420028713228	K191158	000
05420028713235	K191158	000
05420028713259	K191158	000
05420028729151	K191158	000
05420028729229	K191158	000
05420028712047	K191158	000
05420028712030	K191158	000
05420028711972	K191158	000
05420028700570	K191158	000
05420028701300	K191158	000
05420028701317	K191158	000
05420028701324	K191158	000
05420028701331	K191158	000
05420028701768	K191158	000
05420028704820	K191158	000
05420028707425	K191158	000
05420028708408	K191158	000
05420028708415	K191158	000
05420028711620	K191158	000
05420028711798	K191158	000
05420028711927	K191158	000
05420028711941	K191158	000
05420028711958	K191158	000
05420028729281	K191158	000
05420028740262	K191158	000
05420028740279	K191158	000
05420028764671	K191158	000
05420028764848	K191158	000
05420028766293	K191158	000
05420028767450	K191158	000
05420028771228	K191158	000
05420028771600	K191158	000
05420028772898	K191158	000
05420028773208	K191158	000
05420028774847	K191158	000
05420028777428	K191158	000
05420028778449	K191158	000
05420028779927	K191158	000
05420028782125	K191158	000
05420028784723	K191158	000
05420028784839	K191158	000
05420028764602	K191158	000
05420028760079	K191158	000
05420028760062	K191158	000
05420028740286	K191158	000
05420028740293	K191158	000
05420028740439	K191158	000
05420028740743	K191158	000
05420028740811	K191158	000
05420028746653	K191158	000
05420028749395	K191158	000
05420028749562	K191158	000
05420028749920	K191158	000
05420028750124	K191158	000
05420028751503	K191158	000
05420028755341	K191158	000
05420028757123	K191158	000
05420028757130	K191158	000
05420028758823	K191158	000
05420028792889	K191158	000