EFILM VIDEO
FDA 510(k) clearance K013631 · decided 2001-11-20
Clearance details
- K-number
- K013631
- Device name
- EFILM VIDEO
- Applicant
- Efilm Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-05
- Decision date
- 2001-11-20
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LMA
- Device class
- 2
- Regulation number
- 892.2030
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Toronto, Ontario, CA
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DICOM VIDEO (K132183) | Bar Code Computer, Ltd. | 2013-10-03 |
| TELERADPRO EDGE; TELERADPRO EDGE HD-CCD (K130636) | Vidar Systems Corp. | 2013-06-07 |
| DIAGNOSTICPRO EDGE (K130406) | Vidar Systems Corp. | 2013-04-29 |
| TELERADPRO (K102476) | Vidar Systems Corp. | 2010-10-07 |
| VIDAR DENTAL FILM DIGITIZER (K093809) | Vidar Systems Corp. | 2010-01-07 |
| MEDI-6000 MEDICAL IMAGE DIGITIZER (K091288) | Microtek International, Inc. | 2009-08-14 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.