FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)
K Number: K915405
·
Decision Feb 4, 1992
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
2
Review Days
64
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
- P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)
- K Number
- K915405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precise Optics Photo Medic Equipment, Inc.
- Date Received
- December 2, 1991
- Decision Date
- February 4, 1992
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAA), ordered by most recent decision date.
Nexus DRF Digital X-ray Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Insight Enhanced DRF (EN-1002-01)
FDA 510(k)
FDA Class 2
·Radiology
Soteria E-View
FDA 510(k)
FDA Class 2
·Radiology
Adora DRFi (04550010)
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT Mobile Fluoroscopy System
FDA 510(k)
FDA Class 2
·Radiology
ProxiDiagnost N90 / Precision CRF (706110, 706400)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Precise Optics Photo Medic Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921516 | P2900 X-RAY GENERATOR | May 28, 1992 | Substantially Equivalent |