Mini Imager
FDA 510(k) K950423 · Regulatory Management Services
510(k) numberK950423
Submission
- Device name
- Mini Imager
- Applicant
- Regulatory Management Services
San Leandro, CA, US - Received
- February 2, 1995
- Decision date
- May 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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Questions and answers
When was Mini Imager cleared by the FDA?
Mini Imager (K950423) received a 510(k) decision of Substantially Equivalent on May 12, 1995, 99 days after the submission was received.
What is the product code of K950423?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.