Ultrasound Imaging System For Acquiring Images At Home By Lay Users
SGJ is the FDA product code for Ultrasound Imaging System For Acquiring Images At Home By Lay Users, a class II device type, regulated under 21 CFR 892.1590. FDA's definition for this code reads: "An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SGJ
- Device name
- Ultrasound Imaging System For Acquiring Images At Home By Lay Users
- FDA definition
- An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The device provides guidance to lay users to aid image acquisition.
- Regulation
- 21 CFR 892.1590
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SGJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SGJ| Applicant | Clearances |
|---|---|
| Pulsenmore Ltd | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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