Skip to content

Scimage Picomenterprise

by Scimage, Inc.

510(k) K073169

Scimage Picomenterprise is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Scimage, Inc., cleared under FDA 510(k) K073169 on 9 Jan 2008, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073169 Date9 Jan 2008ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K073169

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K073169
UDI-DISize and differences
PicomEnterprise 3.x
Scimage, Inc.
3.x00861917000305
Prescription: no
On the market
Vue Cardio PACS
CARESTREAM HEALTH, INC.
1001890 / Vue Cardio PACS60889971001894
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Scimage, Inc.