FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)
K Number: K864519
·
Decision Feb 13, 1987
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
14
Review Days
88
Basic Information
- Device Name
- PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)
- K Number
- K864519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- PAREXEL INTL. CORP.
- Date Received
- November 17, 1986
- Decision Date
- February 13, 1987
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by PAREXEL INTL. CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K900385 | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE | Jul 9, 1991 | Substantially Equivalent |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | Mar 26, 1991 | Substantially Equivalent |
| K904902 | SMA 26 TRANSDUCER | Mar 26, 1991 | Substantially Equivalent |
| K884800 | ACTA GENOS ELECTROCARDIOGRAPH | Jun 22, 1989 | Substantially Equivalent |
| K862414 | FUJI CR IMAGING PLATE | Feb 26, 1987 | Substantially Equivalent |
| K862416 | FTI 100 MEDICAL THERMAL IMAGER | Jul 1, 1986 | Substantially Equivalent |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Jul 1, 1986 | Substantially Equivalent |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | Aug 20, 1985 | Substantially Equivalent |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Aug 15, 1985 | Substantially Equivalent |
| K851322 | PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH | May 16, 1985 | Substantially Equivalent |