Medical Device Manufacturer · US , Waltham , MA

Planar Systems, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

Recent clearances: PLANAR DOME EX LINE MODEL DOME E2C, PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR, DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY

4
Total
4
Cleared
0
Denied

Planar Systems, Inc. is a display technology company with a manufacturing facility in Waltham, Massachusetts. The company specializes in digital display solutions for professional visualization applications.

Planar received 4 FDA 510(k) clearances from 4 total submissions, all in the Radiology category. The company's regulatory activity spans from 2003 to 2006. This represents a historical record of FDA-cleared Radiology devices, as the company has not pursued new 510(k) submissions in more than 15 years.

Planar's cleared Radiology devices included digital flat-panel display systems designed for diagnostic imaging. These products represented the company's focus on high-performance visualization technology for medical imaging applications during that regulatory period.

For detailed information on specific device names, product models, and clearance dates, review the complete 510(k) submission history.

Regulatory submissions have been managed by Entela, Inc. and Underwriters Laboratories, Inc..

FDA 510(k) Regulatory Record - Planar Systems, Inc.

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