DIAGNOSTICPRO EDGE
FDA 510(k) clearance K130406 · decided 2013-04-29
Clearance details
- K-number
- K130406
- Device name
- DIAGNOSTICPRO EDGE
- Applicant
- Vidar Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-19
- Decision date
- 2013-04-29
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- LMA
- Device class
- 2
- Regulation number
- 892.2030
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Herndon, VA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| DICOM VIDEO (K132183) | Bar Code Computer, Ltd. | 2013-10-03 |
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| FILM DIGITZER, MODEL 2908 MAMMO PRO (K063424) | Array Corp. | 2006-12-21 |
| NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER (K042484) | Nai Technology Products | 2004-10-20 |
| MEDICAL IMAGE DIGITIZER, MODEL 2908 (K033637) | Array Corp. | 2003-12-17 |
| DIGITAL IMAGER (K032022) | Pyramid Medical, Inc. | 2003-09-02 |
| COBRASCAN CR-1 FILMLESS (K022810) | Radiographic Digital Imaging, Inc. | 2002-10-11 |
| FULCRUM (K021949) | Howtek, Inc. | 2002-08-12 |
| LASERPRO 16 (K020243) | Eradlink, Inc. | 2002-03-05 |
Recalls involving this device
No recalls on record reference this clearance.