Oncospace

System, Planning, Radiation Therapy Treatment

Oncospace, Inc.

The following data is part of a premarket notification filed by Oncospace, Inc. with the FDA for Oncospace.

Pre-market Notification Details

• Device ID: K202284
• 510k Number: K202284
• Device Name: Oncospace
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: Oncospace, Inc. 1812 Ashland Ave., Suite 100k Baltimore, MD 21205
• Contact: Praveen Sinha
• Correspondent: Praveen Sinha; Oncospace, Inc. 1812 Ashland Ave., Suite 100k Baltimore, MD 21205
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-12
• Decision Date: 2021-03-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860004284901	K202284	000