ATLASPLAN

Neurological Stereotaxic Instrument

RADIONICS, INC.

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

Pre-market Notification Details

• Device ID: K980584
• 510k Number: K980584
• Device Name: ATLASPLAN
• Classification: Neurological Stereotaxic Instrument
• Applicant: RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516
• Contact: Nichole Riek
• Correspondent: Nichole Riek; RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-02-17
• Decision Date: 1998-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M248ATLASSW1	K980584	000