FDA.reportPublic FDA data

510(k) K980526

Device
Photon Radiosurgery System Prs400
Applicant
PEC PHOTOELECTRON CORP.
510(k) number
K980526
Product code
JAD
Decision
Substantially Equivalent (SESE)
Decision date
1998-07-27
Date received
1998-02-10
Regulation
892.5900
Classification name
System, Therapeutic, X-Ray
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS R VARRICCHIONE
Address
5 Forbes Rd. Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K173425SRT-100+Sensus Healthcare, Inc.2018-03-23
K172080Photoelectric Therapy SystemXstrahl, Ltd.2017-09-29
K162568INTRABEAM 600Carl Zeiss Meditec, AG2016-12-15
K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.2016-02-25
K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesSensus Healthcare2015-10-16
K141343AXXENT CERVICAL APPLICATORIcad, Inc.2014-09-05
K132092ESTEYANucletron B.V.2013-09-26
K131582SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMSensus Healthcare2013-08-28
K130549INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORCarl Zeiss Meditec, Inc.2013-06-26