FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT INFORMATION MANAGER (PIM)
K Number: K921986
·
Decision Oct 16, 1992
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
175
Applicant Total
27
Review Days
171
Basic Information
- Device Name
- PATIENT INFORMATION MANAGER (PIM)
- K Number
- K921986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CONTINENTAL X-RAY CORP.
- Date Received
- April 28, 1992
- Decision Date
- October 16, 1992
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by CONTINENTAL X-RAY CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K972442 | CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 | Sep 11, 1997 | Substantially Equivalent |
| K962140 | ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 | Jul 25, 1996 | Substantially Equivalent |
| K961690 | CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 | Jun 27, 1996 | Substantially Equivalent |
| K954581 | ARC SERIES | Dec 21, 1995 | Substantially Equivalent |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | Mar 31, 1995 | Substantially Equivalent |
| K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | Aug 17, 1994 | Substantially Equivalent |
| K942100 | MODEL TM EP HIGH VOLTAGE GENERATOR | Jun 7, 1994 | Substantially Equivalent |
| K934686 | MOLYBDENUM/RHODIUM FILTERS | May 26, 1994 | Substantially Equivalent |
| K931724 | ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES | Jun 14, 1993 | Substantially Equivalent |
| K925934 | WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT | Mar 4, 1993 | Substantially Equivalent |