Data / Medical devices / United States / Hyland Software, Inc.
Hyland Software, Inc.: FDA-registered device maker in Auburn, CA, United States, 2 510(k) clearances
Hyland Software, Inc. is registered with the FDA (registration 3008596921) in Auburn, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 28, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008596921
- Address
- 12919 Earhart Avenue, Auburn, CA, United States, 95602
- Owner or operator
- Hyland Software, Inc. (9066835)
- Roles
- Manufacturer
- First device listed
- August 30, 2010
- Registered through
- 2026
- Brand names listed
- GearView Basic, GearView QC, MDR Video, MDR Video RP, MDR Video Touch, MDR-VT, Medical Digital Recorder (MDR), PACS Scan and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digitizer, Image, Radiological | LMA | 2 | 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 |
|---|---|---|---|---|---|---|
| January 28, 2009 | K083618 | PACS SCAN | LLZ | Substantially Equivalent | Pacsgear, Inc. | accessdata.fda.gov |
| October 20, 2004 | K042484 | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER | LMA | Substantially Equivalent | Nai Technology Products | accessdata.fda.gov |
Compare with other makers
Updated January 28, 2009. 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.