Siemens Medi Cal Solutions, Inc.
Ann Arbor, MI, US
Siemens Medi Cal Solutions, Inc. appears in FDA device records in Ann Arbor, MI. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Siemens Medi Cal Solutions, Inc. between 2004 and 2020. The busiest year on record is 2016, with 5. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 3 |
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193216 | syngo.CT Lung CAD | OEB | Substantially Equivalent | |
| K182639 | MOBILETT Elara Max | IZL | Substantially Equivalent | |
| K182517 | MULTIX Impact | KPR | Substantially Equivalent | |
| K181279 | Ysio Max | KPR | Substantially Equivalent | |
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | OWB | Substantially Equivalent | |
| K173408 | Mammomat Revelation | MUE | Substantially Equivalent | |
| K172832 | Insight BD | LLZ | Substantially Equivalent | |
| K171766 | Acuson SC2000 Diagnostic Ultrasound System | IYO | Substantially Equivalent | |
| K170315 | Acuson SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K162102 | MAGNETOM Avantofit, MAGNETOM Skyrafit | LNH | Substantially Equivalent | |
| K162417 | Acuson Freestyle Ultrasound System | IYN | Substantially Equivalent | |
| K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K153360 | ADMIRE | JAK | Substantially Equivalent | |
| K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | LNH | Substantially Equivalent | |
| K150493 | Sensis | DQK | Substantially Equivalent | |
| K143319 | Syngo X-workplace SW VD10 | LLZ | Substantially Equivalent | |
| K133643 | SYNGO, CT LIVER ANALYSIS | JAK | Substantially Equivalent | |
| K142628 | Acuson SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K132934 | MULTIX SELECT DR | KPR | Substantially Equivalent | |
| K132094 | CIOS ALPHA | OWB | Substantially Equivalent | |
| K131812 | SENSIS, SENSIS LITE | DQK | Substantially Equivalent | |
| K130754 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K121434 | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO | LNH | Substantially Equivalent | |
| K112020 | SYNGO.CT VASCULAR ANALYSIS | JAK | Substantially Equivalent | |
| K093531 | ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K090334 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K073003 | SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY | JAK | Substantially Equivalent | |
| K062454 | MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES | LNH | Substantially Equivalent | |
| K052423 | MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION | LNH | Substantially Equivalent | |
| K042718 | 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA | MOS | Substantially Equivalent | |
| K042793 | ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) | OWB | Substantially Equivalent | |
| K041029 | KINETDX | LLZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MOSCoil, Magnetic Resonance, Specialty
- DQKComputer, Diagnostic, Programmable
- MUEFull Field Digital, System, X-Ray, Mammographic
- OWBInterventional Fluoroscopic X-Ray System
- OEBLung Computed Tomography System, Computer-Aided Detection
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
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