Company ยท US
Advanced Technology Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2002. Name variants (Inc, Corp, punctuation) are merged.
61510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 20 |
| ITX | Transducer, Ultrasonic, Diagnostic | 7 |
| JOP | Transducer, Ultrasonic | 7 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 6 |
| HGL | Transducer, Ultrasonic, Obstetric | 4 |
| DXK | Echocardiograph | 3 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 |
| LLZ | System, Image Processing, Radiological | 2 |
| DPS | Electrocardiograph | 1 |
| DPT | Probe, Blood-Flow, Extravascular | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| GXW | Echoencephalograph | 1 |
| HGM | System, Monitoring, Perinatal | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2002 | K021966 | Q LAB SOFTWARE Advanced Technology Laboratories, Inc. | LLZ |
| May 4, 2001 | K011224 | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY Advanced Technology Laboratories, Inc. | IYN |
| Sep 28, 2000 | K002144 | MEDLINK DIAGNOSTIC OFFLINE WORKSTATION Advanced Technology Laboratories, Inc. | LLZ |
| Aug 23, 1999 | K992470 | ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | IYO |
| Jun 18, 1999 | K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | IYO |
| Mar 26, 1997 | K961459 | LEVEL 10 HDI Advanced Technology Laboratories, Inc. | IYO |
| Oct 11, 1994 | K935009 | PEGASUS Advanced Technology Laboratories, Inc. | IYN |
| Jul 29, 1994 | K940423 | NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE Advanced Technology Laboratories, Inc. | LMD |
| Feb 28, 1991 | K905248 | NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS Advanced Technology Laboratories, Inc. | DQK |
| Feb 26, 1991 | K903603 | ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) Advanced Technology Laboratories, Inc. | IYO |
| Nov 23, 1990 | K901329 | CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | IYN |
| Nov 8, 1990 | K902214 | BIOPSY NEEDLE TRANSPONDER SYSTEM Advanced Technology Laboratories, Inc. | IYO |
| Oct 22, 1990 | K903348 | ULTRASONIC PULSED DOPPLER IMAGING SYSTEM Advanced Technology Laboratories, Inc. | HGL |
| Mar 13, 1990 | K897004 | NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM Advanced Technology Laboratories, Inc. | DXG |
| Feb 15, 1990 | K896543 | ULTRAMARK 7 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | DXK |
| Dec 18, 1989 | K895647 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. | HGL |
| Nov 13, 1989 | K895123 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. | HGL |
| Sep 12, 1989 | K894054 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. | IYN |
| May 16, 1989 | K891309 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. | IYO |
| Apr 14, 1989 | K881329 | FETAL DOPPLER FOR ULTRAMARK 4 AND 8 Advanced Technology Laboratories, Inc. | HEM |
| Nov 29, 1988 | K881140 | ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY Advanced Technology Laboratories, Inc. | IYO |
| Oct 7, 1988 | K883546 | TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER Advanced Technology Laboratories, Inc. | IYO |
| Feb 19, 1988 | K872441 | HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR Advanced Technology Laboratories, Inc. | DPT |
| Nov 23, 1987 | K873096 | COLOR FLOW IMAGING Advanced Technology Laboratories, Inc. | IYO |
| Sep 30, 1987 | K872068 | HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD Advanced Technology Laboratories, Inc. | DPW |
| Aug 28, 1987 | K871856 | ANNULAR ARRAY SCANHEAD Advanced Technology Laboratories, Inc. | HGL |
| Aug 7, 1987 | K871432 | 3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW Advanced Technology Laboratories, Inc. | ITX |
| Jun 1, 1987 | K871383 | FETALERT ADR FETAL MONITOR Advanced Technology Laboratories, Inc. | HGM |
| Mar 30, 1987 | K870038 | TRT TRANS-RECTAL TRANSDUCER Advanced Technology Laboratories, Inc. | ITX |
| Feb 2, 1987 | K864657 | ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | DXK |
| Jul 16, 1986 | K862681 | ULTRAMARK 1 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | IYO |
| Jul 8, 1986 | K861109 | CW DOPPLER STATIC TRANSDUCERS Advanced Technology Laboratories, Inc. | ITX |
| Jan 6, 1986 | K852947 | ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M Advanced Technology Laboratories, Inc. | ITX |
| Sep 27, 1985 | K853407 | INTRA VAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. | HEM |
| Mar 12, 1985 | K843953 | SCANHEADS ACCESS 10 10PV B10 Advanced Technology Laboratories, Inc. | JOP |
| Mar 12, 1985 | K843620 | SCANHEADS-ACCESS 10PV, BIOSTATIC Advanced Technology Laboratories, Inc. | JOP |
| Mar 5, 1985 | K843911 | ACCESS C Advanced Technology Laboratories, Inc. | JOP |
| Dec 20, 1984 | K843165 | ULTRASOUND 72X & ANNULAR ARRAY SCAN- Advanced Technology Laboratories, Inc. | JOP |
| Dec 20, 1984 | K843131 | ACCESS & 72X ULTRASOUND SCANHEAD UM4 Advanced Technology Laboratories, Inc. | JOP |
| Dec 6, 1984 | K843130 | SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 Advanced Technology Laboratories, Inc. | JOP |
| Dec 6, 1984 | K843129 | SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 Advanced Technology Laboratories, Inc. | JOP |
| Oct 5, 1984 | K842376 | ULTRAMARK 4 ULTRASOUND SYS Advanced Technology Laboratories, Inc. | IYO |
| Sep 27, 1984 | K842093 | MK 700 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | IYO |
| Jun 15, 1984 | K840953 | ACCESS SCANHEADSS Advanced Technology Laboratories, Inc. | IYN |
| May 25, 1984 | K833522 | NEURO SECTOR FIXATION DEVICE Advanced Technology Laboratories, Inc. | GXW |
| Mar 19, 1984 | K840364 | REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY Advanced Technology Laboratories, Inc. | JAA |
| Feb 28, 1984 | K833225 | CALIBRE-TENTATIVE TRADENAME Advanced Technology Laboratories, Inc. | IYO |
| Nov 21, 1983 | K833230 | REGISTREX 1000 DIGITAL RADIOGRAPHY SYS Advanced Technology Laboratories, Inc. | JAA |
| Mar 26, 1982 | K820365 | MARK 100 & 300 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | IYO |
| Mar 26, 1982 | K820364 | MARK 500 ULTRASOUOND SYSTEM Advanced Technology Laboratories, Inc. | IYO |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||