FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
K Number: K160792
·
Decision Apr 15, 2016
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
11
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
- K Number
- K160792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Prometheus Group
- Date Received
- March 23, 2016
- Decision Date
- April 15, 2016
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
ARTHUR
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
Accuro XV
FDA 510(k)
FDA Class 2
·Radiology
QT Scanner 2000 Model A
FDA 510(k)
FDA Class 2
·Radiology
IntraSight Plus
FDA 510(k)
FDA Class 2
·Radiology
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by The Prometheus Group
| K Number | Device Name | ||
|---|---|---|---|
| K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | May 23, 2003 | Substantially Equivalent |
| K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | Feb 19, 2003 | Substantially Equivalent |
| K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 | Jul 31, 2000 | Substantially Equivalent |
| K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR | Feb 22, 2000 | Substantially Equivalent |
| K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | Dec 22, 1997 | Substantially Equivalent |
| K973537 | PATHWAY ELECTROMYOGRAPH | Dec 17, 1997 | Substantially Equivalent |
| K960508 | PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 | Jan 16, 1997 | Substantially Equivalent |
| K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | Aug 7, 1996 | Substantially Equivalent |
| K960762 | SYNERGY PLUS | Jun 13, 1996 | Substantially Equivalent |
| K897132 | PATHWAY II ELECTROMYOGRAPH | Apr 18, 1991 | Substantially Equivalent |