PHOTON RADIOSURGERY SYSTEM (PRS)— 510(k) K992577

Name: FDA 510(k) clearance K992577
Creator: U.S. Food and Drug Administration
Published: 1999-09-23

Substantially Equivalent

Photoelectron Corporation

FDA 510(k) clearance K992577 for PHOTON RADIOSURGERY SYSTEM (PRS), Substantially Equivalent on 1999-09-23. Applicant: Photoelectron Corporation. Device class: 2.

Clearance details

Applicant: Photoelectron Corporation
Product code: Code JAD
Device class: Class 2
Regulation: 21 CFR 892.5900
Advisory panel: Radiology
Date received: 1999-08-02
Decision date: 1999-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAD

view all

K250692 — GentleBeam (GB1000)2025-12-03
K241174 — INTRABEAM (700) +1 more2025-01-10
K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)2023-07-13
K213942 — Esteya2022-01-11
K182641 — Sensus IORT System2019-02-21

More clearances from Photoelectron Corporation

view all

K964947 — PHOTON RADIOSURGERY SYSTEM (PRS)1997-06-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.