510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001163Substantially Equivalent

Dmlc IV-Ergo

3D Line USA, Inc., Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001163 is the FDA 510(k) clearance record for DMLC IV-ERGO, a class II device, cleared for 3D Line USA, Inc. on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 6 510(k) clearances for 3D Line USA, Inc., from to . As of , FDA records show 3 recalls naming K001163.

Clearance record

Decision date
Received
(196 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
3D Line USA, Inc. 2807 Old Ct. Rd., Baltimore MD
510(k) summary
Summary
Third party review
No

Clearances, product code IXI

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