FDA Product Code
FDA Product Code ITX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1570
510(k) Clearances — 415 records · page 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K842687 | BIOMEDICS BLADDER SCANNER | Biomedics | 1985-04-08 | Traditional | PDF ↗ |
| K850422 | ATS ACOUSTIC STANDOFF - WATER BAG | Ats Laboratories, Inc. | 1985-03-27 | Traditional | PDF ↗ |
| K843573 | CIVCO-SUPER SCAN/BIOPSY GUIDE | CIVCO Medical Instruments Co., Inc. | 1984-12-13 | Traditional | PDF ↗ |
| K833224 | BIFOCAL 3.0MHZ | Adr Ultrasound | 1983-11-29 | Traditional | PDF ↗ |
| K812776 | TRANSDUCER ANTISEPTIC TOWELETTE | Echo Laboratories, Inc. | 1982-01-25 | Traditional | PDF ↗ |
| K812929 | 3.5 MHZ BIOPSY TRANSDUCER | General Electric Co. | 1981-11-24 | Traditional | PDF ↗ |
| K812301 | VARIABLE FOCUS 3.5 MHZ TRANSDUCER | Adr Ultrasound | 1981-11-16 | Traditional | PDF ↗ |
| K811843 | BIOPSY TRANSDUCER | Siemens Gammasonics, Inc. | 1981-08-25 | Traditional | PDF ↗ |
| K810748 | 7.5 MHZ WP TRANSDUCER | General Electric Co. | 1981-06-19 | Traditional | PDF ↗ |
| K810749 | 5 MHZ TRANSDUCER | General Electric Co. | 1981-04-17 | Traditional | PDF ↗ |
| K802438 | MARK V DUPLEX ULTRASONIC SCAN SYS. | Advanced Technology Laboratories, Inc. | 1981-01-21 | Traditional | PDF ↗ |
| K801971 | IN-LINE SCAN HEAD MODIFICATION MARK III | Advanced Technology Laboratories, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801973 | IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA | Advanced Technology Laboratories, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K781649 | ULTRASONIC TRANSDUCERS | Echo Laboratories, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K780651 | ULTRASONIC DIAGNOSTIC TRANSDUCER | Hoffrel Instruments, Inc. | 1978-05-09 | Traditional | PDF ↗ |
Product code ITX · Class II · Radiology. Data: openFDA.