Philips Computed Radiography System (PCR)
FDA 510(k) K864519 · Parexel Intl. Corp.
510(k) numberK864519
Submission
- Device name
- Philips Computed Radiography System (PCR)
- Applicant
- Parexel Intl. Corp.
Cambridge, MA, US - Received
- November 17, 1986
- Decision date
- February 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Philips Computed Radiography System (PCR) cleared by the FDA?
Philips Computed Radiography System (PCR) (K864519) received a 510(k) decision of Substantially Equivalent on February 13, 1987, 88 days after the submission was received.
What is the product code of K864519?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.