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Sign in to claim this brandANALOGIC CORPORATION
US
Last updated May 27, 2026
What ANALOGIC CORPORATION makes
Analogic Corporation manufactures single-use probes for stereotactic surgery systems, including tracked and non-tracked variants designed for precision-guided procedures. The company also produces handheld ultrasound imaging systems for body-surface applications, such as the Sonic Window, along with sterile transducer covers for infection control. Additionally, it develops full-body computed tomography (CT) systems for detailed medical imaging.
The company’s devices are classified under FDA Class II regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are intended for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Analogic Corporation manufacture?
Analogic Corporation specializes in three primary categories of medical devices: single-use stereotactic surgery system probes (including tracked and non-tracked variants), handheld ultrasound imaging systems for body-surface applications like the Sonic Window, and sterile transducer covers for ultrasound transducers. Additionally, the company develops full-body computed tomography (CT) systems for advanced imaging.
Where is Analogic Corporation based, and where are its devices primarily intended for use?
Analogic Corporation is based in the United States. The company’s devices are designed and intended for use within the U.S. regulatory environment, where they are subject to FDA oversight.
Which regulatory databases list Analogic Corporation’s devices?
Analogic Corporation’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries help track and categorize medical devices that have undergone the necessary regulatory pathways for commercialization in the U.S.
How are Analogic Corporation’s devices classified under FDA regulations?
Analogic Corporation’s devices fall under FDA Class II classification. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bkultrasound.com
- —
- —
- [email protected]
- Phone
- 1-604-279-8550
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 019677418
Catalogue (83)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anatom 1000 (a Minus, A-) | K974455 | FDA 510(k) | Class II | Active |
| Synerad Omni, Models An6255 And An6265 | K071430 | FDA 510(k) | Class II | Active |
| Sirecust 400 System Patient Monitoring | K802113 | FDA 510(k) | Class II | Active |
| Siemens Sirecust Models 403p, 403-2p & 403n | K855096 | FDA 510(k) | Class II | Active |
| Synerad Multi Digital X-Ray System, Model An6150 | K040995 | FDA 510(k) | Class II | Active |
| Ctxx85 | K182147 | FDA 510(k) | Class II | Active |
| Siemens Sirecust System | K822091 | FDA 510(k) | N/A | Active |
| Fetalgard 3000 - Models Ip1, Ip2, Ap2 And Ap3 | K950420 | FDA 510(k) | Class II | Active |
| Fetalgard 3000 Fetal Monitor | K983395 | FDA 510(k) | Class II | Active |
| Computed Radiography Quality Assurance Software | K980168 | FDA 510(k) | Class II | Active |
| Synerad Omni, Digital X-Ray System, Model An6250 | K043025 | FDA 510(k) | Class II | Active |
| Npb-4000 | K962424 | FDA 510(k) | Class II | Active |
| Webrad Computed Radiography Quality Assurance Workstation | K991626 | FDA 510(k) | Class II | Active |
| Ob-1 Fetal Monitor | K011304 | FDA 510(k) | Class II | Active |
| C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional Printer For Ci, Model M3925a | K041376 | FDA 510(k) | Class II | Active |
| An5150 And An7150 Digital Radiology Systems | K033345 | FDA 510(k) | Class II | Active |
| Sonic Window | K140126 | FDA 510(k) | Class II | Active |
| C3 Patient Monitor | K030931 | FDA 510(k) | Class II | Active |
| Synepix 4600 Detector | K070829 | FDA 510(k) | Class II | Active |
| Digital Image Communications System | K933103 | FDA 510(k) | Class I | Active |
| Dr5000 Dedicated Chest X-Ray System | K001341 | FDA 510(k) | Class II | Active |
| Fetalgard 2000 | K910169 | FDA 510(k) | Class II | Active |
| Sirecust 456 | K830028 | FDA 510(k) | Class II | Active |
| Fetalgard Lite | K002503 | FDA 510(k) | Class II | Active |
| Anatom 2000 | K944131 | FDA 510(k) | Class II | Active |
| Patient Monitor #404 | K831319 | FDA 510(k) | Class II | Active |
| Sirecust 400 | K830029 | FDA 510(k) | Class II | Active |
| CTxx85 CT Scanner | K201231 | FDA 510(k) | Class II | Active |
| Npb3900 Series Patient Monitors | K980411 | FDA 510(k) | Class II | Active |
| Fetalgard Lite-Nibp, Model Fgl-Nibp | K051903 | FDA 510(k) | Class II | Active |
| Sonic Window | K161342 | FDA 510(k) | Class II | Active |
| Lifegard Ii Family Multi-Function Patient Monitor, Models An4320, An4320p, An4321p, An4322p & An3423p | K050919 | FDA 510(k) | Class II | Active |
| Ct6485, Ct12885 | K172058 | FDA 510(k) | Class II | Active |
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