Digicam LHP (Digital Laser High Performance)
FDA 510(k) K883324 · Siemens Gammasonics, Inc.
510(k) numberK883324
Submission
- Device name
- Digicam LHP (Digital Laser High Performance)
- Applicant
- Siemens Gammasonics, Inc.
Des Plaines, IL, US - Received
- August 5, 1988
- Decision date
- February 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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Questions and answers
When was Digicam LHP (Digital Laser High Performance) cleared by the FDA?
Digicam LHP (Digital Laser High Performance) (K883324) received a 510(k) decision of Substantially Equivalent on February 27, 1989, 206 days after the submission was received.
What is the product code of K883324?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.