Imex Medical Systems, Inc. Imexlab 9100
FDA 510(k) K973562 · Imex Medical Systems, Inc.
510(k) numberK973562
Submission
- Device name
- Imex Medical Systems, Inc. Imexlab 9100
- Applicant
- Imex Medical Systems, Inc.
Golden, CO, US - Received
- September 19, 1997
- Decision date
- April 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IYN
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|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
More from Beijing Konted Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
|---|---|---|
| K973556 | Imex Medical Systems, Inc. Imexlab 9000IYN · Traditional | 04/24/1998SE |
| K973336 | Imex StethodopJAF · Traditional | 02/05/1998SE |
| K970156 | Imex Futuraldop ProIYO · Traditional | 04/04/1997SE |
| K942243 | Imex 8000 Personal Cascular LabIYO · Traditional | 11/03/1995SE |
| K944196 | Imwxdop IrJAF · Traditional | 05/12/1995SE |
| K942441 | Imexdop Ct+JAF · Traditional | 08/23/1994SE |
| K910462 | Pocket Dop 3HEP · Traditional | 06/24/1991SE |
| K901593 | Imex Dop-Tone IIKNG · Traditional | 07/02/1990SE |
| K896613 | Flat Vascular ProbeDPW · Traditional | 02/16/1990SE |
| K882138 | Imexlab 3000 Vascular Diagnostic RecorderDPW · Traditional | 11/07/1988SE |
Questions and answers
When was Imex Medical Systems, Inc. Imexlab 9100 cleared by the FDA?
Imex Medical Systems, Inc. Imexlab 9100 (K973562) received a 510(k) decision of Substantially Equivalent on April 15, 1998, 208 days after the submission was received.
What is the product code of K973562?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.