Franklin Quantic 1200
by Bruce Franklin, Inc. 510(k)
Active
510(k) K822236
Overview
The Franklin Quantic 1200 is an echocardiograph device classified under regulation number 870.2330 and product code DXK. It is designed for use in cardiovascular medical specialty applications as an ultrasound imaging system for echocardiographic examinations.
The device was cleared via the FDA 510(k) process under submission K822236 with a substantially equivalent decision granted on August 31, 1982. It is a Class II medical device manufactured by Bruce Franklin, Inc. and is intended for use in clinical settings where cardiovascular imaging is performed.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822236 | Date31 Aug 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Franklin Quantic 1200 used for?
The Franklin Quantic 1200 is designed for use in cardiovascular medical specialty applications as an ultrasound imaging system for echocardiographic examinations, intended for clinical settings where cardiovascular imaging is performed.
How was the Franklin Quantic 1200 cleared for market?
The Franklin Quantic 1200 was cleared via the FDA 510(k) process under submission K822236, with a substantially equivalent decision granted on August 31, 1982, based on its classification under regulation number 870.2330 and product code DXK.
What regulatory classification does the Franklin Quantic 1200 have?
The Franklin Quantic 1200 is classified as a Class II medical device under FDA regulation number 870.2330 and product code DXK, as indicated in its 510(k) clearance documentation and openFDA listing.