3M Laser Imager
FDA 510(k) K843502 · 3M Company
510(k) numberK843502
Submission
- Device name
- 3M Laser Imager
- Applicant
- 3M Company
Monrovia, CA, US - Received
- September 6, 1984
- Decision date
- November 29, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Laser Imager cleared by the FDA?
3M Laser Imager (K843502) received a 510(k) decision of Substantially Equivalent on November 29, 1984, 84 days after the submission was received.
What is the product code of K843502?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.