Advanced Technology Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 60
What Advanced Technology Laboratories, Inc. makes
Advanced Technology Laboratories, Inc. manufactures ultrasound systems and transducers, including the Ultramark 4, Ultramark 9, and HDI 5000 series, which feature advanced imaging capabilities such as assisted border detection and panoramic measurements. Their portfolio also includes transesophageal echocardiography (TEEC) probes, annular array scanheads, and cephalic Doppler units designed for vascular assessments. Additional offerings comprise electrocardiograph devices like the Vitastat ECG-1/ECG-3 and duplex ultrasonic scanning systems, such as the Mark V.
The company’s devices are regulated under FDA pathways, including 510(k) clearances and PMA submissions, with classifications spanning Class I and Class II. These products are listed in the FDA’s 510(k) and PMA registries, reflecting their authorised status for medical use in the United States.
Catalogue
Search and filter all 60 devicesIn-Line Scan Head Modification Mark Iii Ref K801971
Regimes: 510(k) Registry: 510(k)True Spectrum Analysis/Mark Iv Duplex Ref K801972
Regimes: 510(k) Registry: 510(k)Mark 500 System Ref K810073
Regimes: 510(k) Registry: 510(k)Access C Ref K843911
Regimes: 510(k) Registry: 510(k)Calibre-Tentative Tradename Ref K833225
Regimes: 510(k) Registry: 510(k)Atl's Mark 100/300 Ultrasound Systems Ref K811572
Regimes: 510(k) Registry: 510(k)Color Flow Imaging Ref K873096
Regimes: 510(k) Registry: 510(k)Pegasus Ref K935009
Regimes: 510(k) Registry: 510(k)Registrex 1000 Digital Radiography Sys Ref K833230
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) PMA, withdrawn Registry: PMA
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