FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
PROcedure Rehearsal Studio
K Number: K153705
·
Decision Sep 2, 2016
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
1
Review Days
254
Basic Information
- Device Name
- PROcedure Rehearsal Studio
- K Number
- K153705
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3DSYSTEMS, SIMBIONIX PRODUCTS
- Date Received
- December 23, 2015
- Decision Date
- September 2, 2016
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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