FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
THD Procto Software System
K Number: K193512
·
Decision Jan 26, 2020
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
13
Review Days
39
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Basic Information
- Device Name
- THD Procto Software System
- K Number
- K193512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thd Spa
- Date Received
- December 18, 2019
- Decision Date
- January 26, 2020
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Thd Spa
| K Number | Device Name | ||
|---|---|---|---|
| K211623 | THD Procto Software System | Jun 24, 2021 | Substantially Equivalent |
| K180135 | THD Anopress with THD SensyProbe | Mar 8, 2018 | Substantially Equivalent |
| K161785 | THD ANOPRESS | Mar 14, 2017 | Substantially Equivalent |
| K141657 | THD REVOLUTION | Feb 24, 2015 | Substantially Equivalent |
| K133687 | THD N-ANO ANOSCOPE | Dec 11, 2013 | Substantially Equivalent |
| K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE | Jun 1, 2012 | Substantially Equivalent |
| K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | Mar 1, 2011 | Substantially Equivalent |
| K093497 | THD BANDY | Jul 15, 2010 | Substantially Equivalent |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | Jun 11, 2009 | Substantially Equivalent |
| K090009 | THD SLIDE ONE | Jan 28, 2009 | Substantially Equivalent |