510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K925892Substantially Equivalent

Solstice XRAY Ring Marker Pad

Solstice Corporation, Portland ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925892 is the FDA 510(k) clearance record for SOLSTICE XRAY RING MARKER PAD, a class I device, cleared for Solstice Corp. on under FDA product code JAC (System, X-Ray, Film Marking, Radiographic). FDA records list one 510(k) clearance for Solstice Corp. As of , FDA records show no recalls naming K925892.

Clearance record

Decision date
Received
(182 days to decision)
Product code
JAC System, X-Ray, Film Marking, Radiographic
Regulation
21 CFR 892.1640
Device class
Class I
Review panel
Radiology
Applicant
Solstice Corp. P.O. Box 1177, Portland ME
510(k) summary
Statement
Third party review
No

Clearances, product code JAC

Trailing 12 months

FDA records hold no clearances under product code JAC in the trailing twelve months.

FDA records show no clearances under product code JAC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260