510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K980526Substantially Equivalent

Photon Radiosurgery System Prs400

Pec Photoelectron Corp., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980526 is the FDA 510(k) clearance record for PHOTON RADIOSURGERY SYSTEM PRS400, a class II device, cleared for Pec Photoelectron Corp. on under FDA product code JAD (System, Therapeutic, X-Ray). FDA records list one 510(k) clearance for Pec Photoelectron Corp. As of , FDA records show no recalls naming K980526.

Clearance record

Decision date
Received
(167 days to decision)
Product code
JAD System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Pec Photoelectron Corp. 5 Forbes Rd., Lexington MA
510(k) summary
Summary
Third party review
No

Clearances, product code JAD

Trailing 12 months
1 clearance under product code JAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260