Autolaser Multi Format Camera
FDA 510(k) K950288 · Afp Imaging Corp.
510(k) numberK950288
Submission
- Device name
- Autolaser Multi Format Camera
- Applicant
- Afp Imaging Corp.
Elmsford, NY, US - Received
- January 25, 1995
- Decision date
- April 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LMC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141454 | Sony Digital Printer UP-D898MD/SONY Hybrid Printer UP-X898MDLMC · Traditional | Sony Electronics, Inc. | 06/26/2014SE |
| K141346 | Sony Hybird Graphic UP-971AD, Sony Hybird Graphic Printer UP-991ADLMC · Traditional | Sony Electronics, Inc. | 06/26/2014SE |
| K111566 | Dryview Chroma Imaging SystemLMC · Traditional | Carestream Health, Inc. | 10/06/2011SE |
| K092280 | Cypher Dicom Print SolutionLMC · Traditional | Virtual Imaging, Inc. | 10/16/2009SE |
| K090469 | Carestream Dryview 5850 Laser ImagerLMC · Traditional | Carestream Health, Inc. | 05/22/2009SE |
| K083522 | Sony UP-DF750 Digital Film ImagerLMC · Traditional | Sony Electronics, Inc. | 01/09/2009SE |
| K081637 | Laser Imager Drypro Model 873LMC · Special | Konica Minolta Medical & Graphic, Inc. | 07/01/2008SE |
| K072680 | Drystar Axys, Model EYZ4ELMC · Special | Agfa Healthcare Corporation | 10/25/2007SE |
| K061999 | Dry Laser Imager, Drypro Model 832LMC · Traditional | Konica Minolta Medical & Graphic, Inc. | 08/15/2006SE |
| K061302 | Digital Printer P6000D Series, Model P6000DULMC · Traditional | Mitsubishi Electric Corporation Kyoto Works | 06/23/2006SE |
More from Mitsubishi Electric Corporation Kyoto Works
| 510(k) | Device | Decision |
|---|---|---|
| K123419 | Eva Select Digital Dental Imaging SystemMUH · Special | 12/27/2012SE |
| K072357 | Newtom VG Computed Tomography X-Ray SystemMUH · Special | 09/18/2007SE |
| K041120 | Ev Apan Digital, Model K1VSM2000MUH · Traditional | 08/30/2004SE |
| K030647 | Eva Digital Dental X-Ray SystemEHD · Special | 03/20/2003SE |
| K014144 | Extoral/Tescera Glazing Resin, Model T-1804EBF · Traditional | 02/07/2002SE |
| K013176 | Modification to: Sens-A-Ray System with Proimage SoftwareEHD · Special | 10/16/2001SE |
| K974619 | Scanaray/Cd-Dent Advanced Computerized X-Ray SystemLMA · Traditional | 02/25/1998SE |
| K925885 | Afp 17 X 4 Automatic Film ProcessorIXW · Traditional | 06/09/1993SE |
| K930761 | Image-X 70 Intraoral X-Ray SystemEAP · Traditional | 05/25/1993SE |
| K925684 | Olymp-X,X-Ray GeneratorIZO · Traditional | 02/02/1993SE |
Questions and answers
When was Autolaser Multi Format Camera cleared by the FDA?
Autolaser Multi Format Camera (K950288) received a 510(k) decision of Substantially Equivalent on April 4, 1995, 69 days after the submission was received.
What is the product code of K950288?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.