FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
K Number: K935580
·
Decision Mar 16, 1994
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
81
Applicant Total
13
Review Days
118
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
- PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
- K Number
- K935580
- 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
- Date Received
- November 18, 1993
- Decision Date
- March 16, 1994
- Product Code
- OXO
- 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 |
|---|---|---|---|
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXO), ordered by most recent decision date.
Digital C-ARM with 3D
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan TAU MVP Mini C-Arm System
FDA 510(k)
FDA Class 2
·Radiology
OEC One CFD
FDA 510(k)
FDA Class 2
·Radiology
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan TAU Mini C-Arm
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan VERSA Mini C-Arm
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Precise Optics
| K Number | Device Name | ||
|---|---|---|---|
| K030061 | PS 3000 DIGATAL PHOTOSPOT SYSTEM | Apr 7, 2003 | Substantially Equivalent |
| K932878 | PRECISION INTRA-ORAL SCOPES | Jan 6, 1994 | Substantially Equivalent |
| K914084 | ENDOSCOPES | Jan 22, 1992 | Substantially Equivalent |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | Nov 27, 1991 | Substantially Equivalent |
| K911744 | PRECISION OPTICS CORPORATION LAPAROSCOPE | Jul 26, 1991 | Substantially Equivalent |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | Oct 26, 1990 | Substantially Equivalent |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | Oct 19, 1990 | Substantially Equivalent |
| K903458 | PRECISION OPTICS IMAGE COUPLER | Oct 19, 1990 | Substantially Equivalent |
| K820178 | PI808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |
| K827087 | P1808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |