Infinity Explorer
FDA 510(k) K013515 · Siemens Medical Solutions USA, Inc.
510(k) numberK013515
Submission
- Device name
- Infinity Explorer
- Applicant
- Siemens Medical Solutions USA, Inc.
Danvers, MA, US - Received
- October 22, 2001
- Decision date
- January 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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Questions and answers
When was Infinity Explorer cleared by the FDA?
Infinity Explorer (K013515) received a 510(k) decision of Substantially Equivalent on January 10, 2002, 80 days after the submission was received.
What is the product code of K013515?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.