510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112768Substantially Equivalent

Calypso Systems with Dynamic Edge Gating

Calypso Medical Technologies, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112768 is the FDA 510(k) clearance record for CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING, a class II device, cleared for Calypso Medical Technologies, Inc. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list 5 510(k) clearances for Calypso Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K112768.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LHN System, Radiation Therapy, Charged-Particle, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Calypso Medical Technologies, Inc. 2101 Fourth Ave., Suite 500, Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHN

Trailing 12 months
4 clearances under product code LHN in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260