Medgraphix Intl VR 1000 Series
FDA 510(k) K921381 · Medgraphix Intl.
510(k) numberK921381
Submission
- Device name
- Medgraphix Intl VR 1000 Series
- Applicant
- Medgraphix Intl.
Rosemont, PA, US - Received
- March 23, 1992
- Decision date
- November 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
Questions and answers
When was Medgraphix Intl VR 1000 Series cleared by the FDA?
Medgraphix Intl VR 1000 Series (K921381) received a 510(k) decision of Substantially Equivalent on November 2, 1992, 224 days after the submission was received.
What is the product code of K921381?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.