Teratech Corp.
Burlington, MA, US
TERATECH CORP. appears in FDA device records in Burlington, MA. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Teratech Corp. between 1999 and 2020. The busiest year on record is 2014, with 3. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2001 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2008 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 2 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201633 | Terason uSmart 3200T Plus Ultrasound System | IYN | Substantially Equivalent | |
| K193510 | Terason uSmart3200T Ultrasound System | IYN | Substantially Equivalent | |
| K150533 | Terason uSmart3200T Ultrasound System | IYN | Substantially Equivalent | |
| K150148 | Terason uSmart3300 Ultrasound System | IYN | Substantially Equivalent | |
| K140773 | TERASON USMART3300 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K140834 | TERASON USMART3400 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K140524 | TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K131209 | TERASON USMART3200T ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K112953 | TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS | IYN | Substantially Equivalent | |
| K110482 | PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS | IYN | Substantially Equivalent | |
| K110020 | TERASON T3200 ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K080234 | TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO | IYO | Substantially Equivalent | |
| K051334 | TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER | IYN | Substantially Equivalent | |
| K043278 | TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES | ITX | Substantially Equivalent | |
| K040840 | TERATECH MODEL 10V5 SMART PROBE | ITX | Substantially Equivalent | |
| K030191 | TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K012191 | TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES | IYN | Substantially Equivalent | |
| K010883 | TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE | ITX | Substantially Equivalent | |
| K992505 | TERATECH, MODEL 2000 IMAGING IMAGING | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002315840 | 3002315840 | TERATECH CORP. | 77-79 Terrace Hall Ave, BURLINGTON, MA 01803 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain