Annular Array Scanhead
FDA 510(k) K871856 · Advanced Technology Laboratories, Inc.
510(k) numberK871856
Submission
- Device name
- Annular Array Scanhead
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- May 12, 1987
- Decision date
- August 28, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGL – Transducer, Ultrasonic, Obstetric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2960
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
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| K900966 | EUP-V12 5.0 MHZ Convex Array Transvaginal ProbeHGL · Traditional | Hitachi Medical Corp. of America | 09/12/1990SE |
| K903316 | Aloka UST-964P-5 Endovaginal TransducerHGL · Traditional | Ge Medical Systems Information Technologies | 08/22/1990SE |
| K901142 | Mer Multiplane Vaginal Probe (MVP)HGL · Traditional | Medical Equipment Resources | 08/22/1990SE |
| K900838 | Transvaginal Transducer AssemblyHGL · Traditional | Pie Medical Equipment B.V. | 05/23/1990SE |
| K895449 | Aloka Model SSD-650 Ultrasound Imaging SystemHGL · Traditional | Ge Medical Systems Information Technologies | 03/05/1990SE |
| K881263 | Model 500A Vascular Spectrum Analyzer W/DopplerHGL · Traditional | Multigon Industries, Inc. | 01/05/1990SE |
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Questions and answers
When was Annular Array Scanhead cleared by the FDA?
Annular Array Scanhead (K871856) received a 510(k) decision of Substantially Equivalent for Some Indications on August 28, 1987, 108 days after the submission was received.
What is the product code of K871856?
The FDA product code is HGL – Transducer, Ultrasonic, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.2960.