Pie Medical
Indianpolis, IN, US
Pie Medical appears in FDA device records in Indianpolis, IN. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Pie Medical between 2000 and 2006. The busiest year on record is 2005, with 3. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061961 | ART LAB SOFTWARE | LLZ | Substantially Equivalent | |
| K053154 | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM | IYN | Substantially Equivalent | |
| K043588 | MYLAB 15 / MYLAB 20, MODEL 2700 | IYN | Substantially Equivalent | |
| K043360 | IMT.LAB | LLZ | Substantially Equivalent | |
| K041675 | PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS | IYN | Substantially Equivalent | |
| K033604 | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L | IYO | Substantially Equivalent | |
| K023512 | PICUS ULTRASOUND IMAGING SYSTEMS | IYN | Substantially Equivalent | |
| K020112 | 50S TRINGA ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K003725 | 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS | IYO | Substantially Equivalent | |
| K003292 | 260 CORVUS | IYO | Substantially Equivalent | |
| K002357 | 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS | IYO | Substantially Equivalent | |
| K002880 | 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC | IYN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain