FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
K Number: K972204
·
Decision Oct 8, 1997
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
6
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
- ACU-RAY HF SERIES PORTABLE X-RAY UNIT
- K Number
- K972204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sterne Equipment Co., Ltd.
- Date Received
- June 12, 1997
- Decision Date
- October 8, 1997
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZL), ordered by most recent decision date.
Portable DR Imaging System
FDA 510(k)
FDA Class 2
·Radiology
RAYMO Mobile X-ray System (Model: RAYMO)
FDA 510(k)
FDA Class 2
·Radiology
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
FDA 510(k)
FDA Class 2
·Radiology
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
FDA 510(k)
FDA Class 2
·Radiology
Airbile-100
FDA 510(k)
FDA Class 2
·Radiology
Mobile X-ray unit (!M1)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Sterne Equipment Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K003433 | NEURO-TRAIN III (3) | Jun 15, 2001 | Substantially Equivalent |
| K980158 | MYO-TRAIN V (5) | Jul 28, 1998 | Substantially Equivalent |
| K970155 | NEURO-TRAIN II (2) | Mar 17, 1997 | Substantially Equivalent |
| K931279 | ACU-RAY | Nov 3, 1993 | Substantially Equivalent |
| K883896 | NEUROTRAIN | Jul 14, 1989 | Substantially Equivalent |