DMLC IV-ERGO— 510(k) K001163
Substantially Equivalent3D Line USA, Inc.
FDA 510(k) clearance K001163 for DMLC IV-ERGO, Substantially Equivalent on 2000-10-23. Applicant: 3D Line USA, Inc.. Device class: 2.
Clearance details
- Applicant
- 3D Line USA, Inc.
- Product code
- Code IXI
- Device class
- Class 2
- Regulation
- 21 CFR 892.5710
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code IXI
view allMore clearances from 3D Line USA, Inc.
view allRecalls naming K001163
K-number listed on FDA's recall record- Z-2157-2013 — DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
- Z-0978-2014 — DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001163.
Data sourced from openFDA. This site is unofficial and independent of the FDA.