FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PI808 MOBILE C-ARM IMAGE INTENSIFIER
K Number: K820178
·
Decision Mar 4, 1982
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
13
Review Days
41
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Basic Information
- Device Name
- PI808 MOBILE C-ARM IMAGE INTENSIFIER
- K Number
- K820178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Precise Optics
- Date Received
- January 22, 1982
- Decision Date
- March 4, 1982
- 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 |
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Other Clearances by Precise Optics
| K Number | Device Name | ||
|---|---|---|---|
| K030061 | PS 3000 DIGATAL PHOTOSPOT SYSTEM | Apr 7, 2003 | Substantially Equivalent |
| K935580 | PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER | Mar 16, 1994 | 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 |
| K827087 | P1808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |