510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K080601Substantially Equivalent

Ergo++ Version 1.7

3D Line Medical Systems S.r.l., Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080601 is the FDA 510(k) clearance record for ERGO++ VERSION 1.7, a class II device, cleared for 3D Line Medical Systems S.R.L. on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list 2 510(k) clearances for 3D Line Medical Systems S.R.L., from to . As of , FDA records show 2 recalls naming K080601.

Clearance record

Decision date
Received
(95 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 Medical Systems S.R.L. 4775 Peachtree Industrial Blvd., Norcross GA
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