Advanced Technology Laboratories, Inc.: FDA clearances and approvals
Advanced Technology Laboratories, Inc. has 61 FDA 510(k) clearances (first 1980, latest 2002), plus 1 PMA decision, across 17 product codes in 4 review panels. Median 510(k) review time: 97 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 20 | 20 |
| ITX | Transducer, Ultrasonic, Diagnostic | 7 | 7 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 6 |
| JOP | Transducer, Ultrasonic | 7 | 7 |
| HGL | Transducer, Ultrasonic, Obstetric | 4 | 4 |
| DXK | Echocardiograph | 3 | 3 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 2 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
Plus 7 more product codes.
Review panels
- Radiology (39)
- Cardiovascular (15)
- Obstetrics and Gynecology (7)
- Neurology (1)
Most recent Advanced Technology Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021966 | Q LAB SOFTWARE | LLZ | 2002-07-02 | 15 |
| K011224 | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | IYN | 2001-05-04 | 14 |
| K002144 | MEDLINK DIAGNOSTIC OFFLINE WORKSTATION | LLZ | 2000-09-28 | 73 |
| K992470 | ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM | IYO | 1999-08-23 | 28 |
| K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 1999-06-18 | 32 |
| K961459 | LEVEL 10 HDI | IYO | 1997-03-26 | 344 |
| K935009 | PEGASUS | IYN | 1994-10-11 | 356 |
| K940423 | NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE | LMD | 1994-07-29 | 179 |
| K905248 | NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS | DQK | 1991-02-28 | 99 |
| K903603 | ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) | IYO | 1991-02-26 | 202 |
51 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940005 | PMA | ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM | 1996-04-11 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Technology Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Advanced Technology Laboratories, Inc. have?
Advanced Technology Laboratories, Inc. has 61 FDA 510(k) clearances (first 1980, latest 2002), plus 1 PMA decision, across 17 product codes in 4 review panels.
How long does FDA take to clear Advanced Technology Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Technology Laboratories, Inc.'s cleared 510(k)s is 97 days.
What devices does Advanced Technology Laboratories, Inc. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 20); ITX (Transducer, Ultrasonic, Diagnostic, 7); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7).
Has Advanced Technology Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Technology Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 61 Advanced Technology Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Advanced Technology Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.