# Instrumentarium Imaging, Inc.

- Location (FDA's records): Milwaukee, WI
- FDA decisions: 24 (1989–2000): 24 510(k) clearances
- Product codes: LNH (14), IZH (6), OXO (1), IZX (1), MUH (1), EHD (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Instrumentarium Corp. Imaging Division: 3 (https://510kreport.com/company/instrumentarium-imaging-division)
- J. Morita USA, Inc.: 1 (https://510kreport.com/company/j-morita-usa)
- Instrumentarium Dental, Inc.: 1 (https://510kreport.com/company/instrumentarium-dental)
- J. Morita Mfg. Corp.: 1 (https://510kreport.com/company/j-morita-mfg)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)

## Its most-cited devices
- K973642: Orthopantomograph OP100 and Orthoceph OC100 (1997), cited by 4
- K002472: Delta 32 and Delta 32 Tact (2000), cited by 1
- K000976: Diamond (Mammographic X-Ray System) (2000), cited by 1
- K925987: Instrumentarium MEGA4 HT (1993), cited by 1

## Recent decisions
- K002472: Delta 32 and Delta 32 Tact (Nov 29, 2000)
- K001928: SIGMA (Aug 2, 2000)
- K000976: Diamond (Mammographic X-Ray System) (Jun 1, 2000)
- K001171: Delta 16 Tact (May 12, 2000)
- K973642: Orthopantomograph OP100 and Orthoceph OC100 (Nov 21, 1997)
- K955411: DELTA 16 (Mar 21, 1996)
- K925987: Instrumentarium MEGA4 HT (May 19, 1993)
- K924921: Instrumentarium MEGA4 HT (May 17, 1993)

Source page: https://510kreport.com/company/instrumentarium-imaging