Surgplan and Panplan
FDA 510(k) K041078 · Imaging Sciences Intl., Inc.
510(k) numberK041078
Submission
- Device name
- Surgplan and Panplan
- Applicant
- Imaging Sciences Intl., Inc.
Hatfield, PA, US - Received
- April 26, 2004
- Decision date
- December 23, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Surgplan and Panplan cleared by the FDA?
Surgplan and Panplan (K041078) received a 510(k) decision of Substantially Equivalent on December 23, 2004, 241 days after the submission was received.
What is the product code of K041078?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.