PUCK U & UD CUTFILM CHANGERS
FDA 510(k) clearance K842911 · decided 1984-08-21
Clearance details
- K-number
- K842911
- Device name
- PUCK U & UD CUTFILM CHANGERS
- Applicant
- Elema-Schonander, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-23
- Decision date
- 1984-08-21
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- KPX
- Device class
- 2
- Regulation number
- 892.1860
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRANS X-1000 (K945635) | Canon USA, Inc. | 1995-02-01 |
| ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES (K935157) | Regulatory Consultants TO the Medical Device Indus | 1994-08-09 |
| NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS (K934850) | Victoreen, Inc. | 1993-11-22 |
| BCM-600TX (K933035) | B C Medical , Ltd. | 1993-10-08 |
| BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (K925598) | Acoma Medical Imaging, Inc. | 1993-02-01 |
| MWX-7440 HIGH SPEED BUCKY (K924423) | Midwest X-Ray Equipment Co. | 1993-01-15 |
| SHIMADZU RADIOGRAPJHIC STAND BR-100 (K925169) | Shimadzu Medical Systems | 1992-12-03 |
| OX-600 (K920196) | Stardard X-Ray Sales Co. | 1992-10-14 |
| DU PONT COMPACT DAYLIGHT SYSTEM 2000 (K922483) | E.I. Dupont DE Nemours & Co., Inc. | 1992-09-11 |
| FRANKLIN 9000 WALL STAND (K905789) | Mallinckrodt Group, Inc. | 1991-05-20 |
| AUTOMATIC CASSETTE LOADER (K902761) | Mallinckrodt Group, Inc. | 1990-10-09 |
| PUCK 90M (K903576) | Elema-Schonander, Inc. | 1990-09-04 |
Recalls involving this device
No recalls on record reference this clearance.