510(k) K011949
- Device
- ELK LASER IMAGER, MODEL EL-DRY 4000
- Applicant
- NISHIMOTO SANGYO CO., LTD.
- 510(k) number
- K011949
- Product code
- LMC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-29
- Date received
- 2001-06-21
- Regulation
- 892.2040
- Classification name
- Camera, Multi Format, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- GARY J ALLSEBROOK
- Address
- 16303 Panoramic Way San Leandro CA US 94578 94578
FDA Registration Numbers
- 3008787461
- 1054713
- 3015276088
- 3001722928
- 9613152
- 3001556265
- 3011682748
- 3004485675
- 3005406110
- 3005810333
- 3011802799
- 3016527960
- 3004977335
- 1530958
- 3004091527
- 3003769120
Source Documents
Other 510(k) Records For Product Code LMC
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|---|---|---|---|
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| K141346 | SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD | Sony Electronics, Inc. | 2014-06-26 |
| K111566 | DRYVIEW CHROMA IMAGING SYSTEM | Carestream Health, Inc. | 2011-10-06 |
| K092280 | CYPHER DICOM PRINT SOLUTION | Virtual Imaging, Inc. | 2009-10-16 |
| K090469 | CARESTREAM DRYVIEW 5850 LASER IMAGER | Carestream Health, Inc. | 2009-05-22 |
| K083522 | SONY UP-DF750 DIGITAL FILM IMAGER | Sony Electronics, Inc. | 2009-01-09 |
| K081637 | LASER IMAGER DRYPRO MODEL 873 | Konica Minolta Medical & Graphic, Inc. | 2008-07-01 |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | Agfa Healthcare Corporation | 2007-10-25 |
| K061999 | DRY LASER IMAGER, DRYPRO MODEL 832 | Konica Minolta Medical & Graphic, Inc. | 2006-08-15 |
| K061302 | DIGITAL PRINTER P6000D SERIES, MODEL P6000DU | Mitsubishi Electric Corporation Kyoto Works | 2006-06-23 |
| K060440 | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER | Codonics, Inc. | 2006-03-16 |
| K052251 | DRYSTAR MODEL 5500 | Agfa Corporation | 2005-08-31 |
| K042133 | DRY LASER IMAGER, MODEL DRYPRO MODEL 793 | Konica Minolta Medical & Graphic, Inc. | 2004-11-24 |
| K042232 | NP-2600 SERIES HARDCOPY PRINTERS | Codonics, Inc. | 2004-10-05 |
| K042158 | KODAK MEDICAL IMAGER 300 | Eastman Kodak Company | 2004-09-24 |
Legacy Summary
summary
FDA Review
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