510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031281Substantially Equivalent

Ergo Srs

3D Line USA, Inc., Owings Mills MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031281 is the FDA 510(k) clearance record for ERGO SRS, a class II device, cleared for 3D Line USA, Inc. on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list 6 510(k) clearances for 3D Line USA, Inc., from to . As of , FDA records show no recalls naming K031281.

Clearance record

Decision date
Received
(245 days to decision)
Product code
MUJ System, Planning, Radiation Therapy Treatment
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
3D Line USA, Inc. 11419 Crownridge Rd., Suite 15, Owings Mills MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUJ

Trailing 12 months
12 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 20260