510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K001295Substantially Equivalent

Piper

Rtek Medical Systems, LLC, Pittsford NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001295 is the FDA 510(k) clearance record for PIPER, a class II device, cleared for Rtek Medical Systems, LLC on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list one 510(k) clearance for Rtek Medical Systems, LLC. As of , FDA records show no recalls naming K001295.

Clearance record

Decision date
Received
(184 days to decision)
Product code
MUJ System, Planning, Radiation Therapy Treatment
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Rtek Medical Systems, LLC 16 Tobey Village Office Park, Pittsford NY
510(k) summary
Summary
Third party review
No

Clearances, product code MUJ

Trailing 12 months
13 clearances under product code MUJ in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MUJ, trailing twelve months
MonthClearances
November 20251
December 20253
January 20260
February 20262
March 20261
April 20260
May 20263
June 20261
July 20261
August 20260
September 20260
October 20261