THD Procto Software System
510(k) K211623
THD Procto Software System is a medical device (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Thd SpA, cleared under FDA 510(k) K211623 on 24 Jun 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211623 | Date24 Jun 2021 | StatusActive |
Official records
- FDA 510(k) database K211623
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYO
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K211623
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| THD Procto Software System | 760004 / THD Procto Software | 08033737713037 | — | On the market |
| THD Procto Software System THD 4K CAM | 800195 / THD 4K CAM | 18033737712341 | — | On the market |
| THD Procto Software System THD DIGITAL MOBILE | 800306 / THD DIGITAL MOBILE | 68051887043295 | — | On the market |
| THD Procto Software System THD DIGITAL MOBILE ADVANCED | 800309 / THD DIGITAL MOBILE ADVANCED | 68051887043325 | — | On the market |
| THD Procto Software System THD DIGITAL MOBILE ECOGRAPHY | 800308 / THD DIGITAL MOBILE ECOGRAPHY | 68051887043318 | — | On the market |
| THD Procto Software System THD DIGITAL MOBILE LIGHT | 800320 / THD DIGITAL MOBILE LIGHT | 68051887046715 | — | On the market |
| THD Procto Software System THD DIGITAL MOBILE MANOMETRY | 800307 / THD DIGITAL MOBILE MANOMETRY | 68051887043301 | — | On the market |
| THD Procto Software System THD HRStation | 800299 / THD HRStation | 58051887042642 | — | On the market |
| THD Procto Software System THD Proctostation | 800198 / THD Proctostation | 18033737712389 | — | On the market |
Similar devices
Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).
- uSONIQUE uSONIQUE Pulse by Wuhan United Imaging Healthcare Co., Ltd.
- OPHTHASCAN MINI-B by Biophysic Medical, Inc.
- CIRAS ULTRASONIC SCANNING SYSTEM by Ausonics Pty, Ltd.
- SONOGEL by Sonotech, Inc.
- APA-C CATALOG NUMBER A-8001-C by Ausonics Pty, Ltd.
- Integrated Needle Guide H46332LY, H46332LY-5 by CIVCO MEDICAL INSTRUMENTS CO., INC.
- ALLERGAN HUMPHREY A/B SCAN, MODEL 835 by Allergan Humphrey
- ECHO SCAN, EASY SCAN by Tomtec Imaging Systems GmbH
- Ultrasound System SONIMAGE HS1 A9RP by KONICA MINOLTA, INC.
- BLADDERSCAN BVI 9400 ULTRASOUND by Verathon Incorporated