Medis Medical Imaging Systems, B.V.
LEIDEN Zuid-Holland, NL
MEDIS MEDICAL IMAGING SYSTEMS, B.V. appears in FDA device records in LEIDEN Zuid-Holland, NL. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Medis Medical Imaging Systems, B.V. between 1994 and 2019. The busiest year on record is 2004, with 4. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 4 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182611 | Qangio XA 3D | QHA | Substantially Equivalent | |
| K140587 | MR-CT VVA | LLZ | Substantially Equivalent | |
| K112807 | X-RAY VVA | LLZ | Substantially Equivalent | |
| K073156 | QPLAQUE MR | LNH | Substantially Equivalent | |
| K062386 | QANGIO CT | JAK | Substantially Equivalent | |
| K050703 | QBRAIN | LLZ | Substantially Equivalent | |
| K042383 | RSA-CMS | LLZ | Substantially Equivalent | |
| K041162 | ORTHO-CMS | LLZ | Substantially Equivalent | |
| K040746 | MRA-CMS | LLZ | Substantially Equivalent | |
| K033774 | CT-MASS | JAK | Substantially Equivalent | |
| K023970 | QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS | IZI | Substantially Equivalent | |
| K011582 | QCU ANALYTICAL SOFTWARE PACKAGE | LLZ | Substantially Equivalent | |
| K994283 | MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM | LNH | Substantially Equivalent | |
| K994282 | MRI- FLOW ANALYTICAL SOFTWARE PACKAGE | LNH | Substantially Equivalent | |
| K993761 | CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW | LLZ | Substantially Equivalent | |
| K993765 | QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) | IZI | Substantially Equivalent | |
| K993763 | QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) | IZI | Substantially Equivalent | |
| K940172 | CARDIOVASCULAR MEASUREMENT SYSTEM-CMS | IZI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614587 | 3006974930 | MEDIS MEDICAL IMAGING SYSTEMS, B.V. | SCHUTTERSVELD 9, LEIDEN Zuid-Holland 2316 XG NL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain