AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER

Accelerator, Linear, Medical

AKTINA MEDICAL PHYSICS CORP.

The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medicalphysics Corporation Mechanical Frontpointer.

Pre-market Notification Details

• Device ID: K990997
• 510k Number: K990997
• Device Name: AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
• Classification: Accelerator, Linear, Medical
• Applicant: AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920
• Contact: Joan Z Acharopoulos
• Correspondent: Joan Z Acharopoulos; AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-03-25
• Decision Date: 1999-06-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B365531040	K990997	000
B365503400	K990997	000
B365113600	K990997	000