GammaPod

System, Radiation Therapy, Radionuclide

Xcision Medical Systems, LLC

The following data is part of a premarket notification filed by Xcision Medical Systems, Llc with the FDA for Gammapod.

Pre-market Notification Details

• Device ID: K180571
• 510k Number: K180571
• Device Name: GammaPod
• Classification: System, Radiation Therapy, Radionuclide
• Applicant: Xcision Medical Systems, LLC 9176 Red Branch Road Columbia, MD 21045
• Contact: Daniel R. Plonski
• Correspondent: Daniel R. Plonski; Xcision Medical Systems, LLC 9176 Red Branch Road Columbia, MD 21045
• Product Code: IWB
• CFR Regulation Number: 892.5750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-05
• Decision Date: 2018-04-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10850002615361	K180571	000
10850002615118	K180571	000
10850002615125	K180571	000
10850002615132	K180571	000
10850002615149	K180571	000
10850002615156	K180571	000
10850002615163	K180571	000
10850002615170	K180571	000
10850002615187	K180571	000
10850002615194	K180571	000
10850002615101	K180571	000
10850002615095	K180571	000
10850002615088	K180571	000
10850002615378	K180571	000
10850002615385	K180571	000
10850002615392	K180571	000
10850002615408	K180571	000
10850002615415	K180571	000
10850002615422	K180571	000
10850002615439	K180571	000
10850002615446	K180571	000
10850002615453	K180571	000
10850002615200	K180571	000
10850002615217	K180571	000
10850002615347	K180571	000
10850002615354	K180571	000
00850002615005	K180571	000
00850002615012	K180571	000
00850002615029	K180571	000
00850002615036	K180571	000
00850002615043	K180571	000
00850002615050	K180571	000
00850002615067	K180571	000
10850002615330	K180571	000
10850002615323	K180571	000
10850002615316	K180571	000
10850002615224	K180571	000
10850002615231	K180571	000
10850002615248	K180571	000
10850002615255	K180571	000
10850002615262	K180571	000
10850002615279	K180571	000
10850002615286	K180571	000
10850002615293	K180571	000
10850002615309	K180571	000
00850002615074	K180571	000