Data / Medical devices / United States / Scimage, Inc.
Scimage, Inc.: FDA-registered device maker in Los Altos, CA, United States, 3 510(k) clearances
Scimage, Inc. is registered with the FDA (registration 2952596) in Los Altos, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 8, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2952596
- FEI number
- 3000206530
- Address
- 4916 El Camino Real, Suite 200, Los Altos, CA, United States, 94022
- Owner or operator
- SCIMAGE, INC. (9026453)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 13, 1996
- Registered through
- 2026
- Brand names listed
- Netra Workstation and NetraMD Software, PicomEnterprise
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2017 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP | MWI | Substantially Equivalent | Fysicon BV | accessdata.fda.gov |
| January 9, 2008 | K073169 | SCIMAGE PICOMENTERPRISE | LLZ | Substantially Equivalent | Scimage, Inc. | accessdata.fda.gov |
| January 19, 2001 | K003484 | NETRA WORKSTATION AND NETRAMD SOFTWARE | LLZ | Substantially Equivalent | Scimage, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Computer, Diagnostic, Programmable
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of System, Digital Image Communications, Radiological
Updated September 8, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.