Scimage, Inc.
United StatesFDA applicant, unverified FDA FEI 3000206530
Scimage, Inc. is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) as of 15 Nov 2026.
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 3
- FDA GUDID 1
- Device classes
- FDA Class II 3
- FDA Class I 1
- Identifiers
- FDA FEI 3000206530
- DUNS 958220790
At a glance
Market reach
- United States
- FDA FEI
Catalogue
- Regimes: 510(k) Registry: GUDID
Netra Workstation And Netramd Software Ref K003484
Regimes: 510(k) Registry: 510(k)Netra Workstation System & Netra Md Software Ref K960911
Regimes: 510(k) Registry: 510(k)Scimage Picomenterprise Ref K073169
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3000206530
- DUNS number
- 958220790
- Address
- 4916 EL CAMINO REAL, SUITE 200, LOS ALTOS, CA, 94022
- Phone
- 866-724-6243
Frequently asked questions
How many devices does Scimage, Inc. have in the registry?
The registry currently lists 4 devices for Scimage, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scimage, Inc.'s devices?
Among its 4 most recently registered devices, Scimage, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Scimage, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Scimage, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scimage, Inc. in the registry?
The most recently registered devices listed for Scimage, Inc. include PicomEnterprise 3.x, NETRA WORKSTATION AND NETRAMD SOFTWARE, NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE and SCIMAGE PICOMENTERPRISE.